Ultrasonic surgical instrument with removable shaft assembly portion

ABSTRACT

An apparatus includes a body, a shaft assembly, and an end effector. The shaft assembly includes an outer tube, a proximal inner tube member, a distal inner tube member, and an acoustic waveguide. The end effector includes an ultrasonic blade and a clamp arm. A first portion of the clamp arm is pivotably coupled with a distal end of the outer tube. A second portion of the clamp arm is pivotably coupled with a distal end of the distal inner tube member. The outer tube is configured to removably couple with the body and the distal inner tube member is configured to removably couple with the proximal inner tube member such that the outer tube, the distal inner tube member, and the clamp arm are configured to removably couple with the body and the remainder of the shaft assembly and end effector as a unit.

PRIORITY

This application claims priority to U.S. Provisional Pat. App. No.62/242,440, entitled “Ultrasonic Surgical Instrument with DisposableOuter Tube,” filed Oct. 16, 2015, the disclosure of which isincorporated by reference herein.

This application also claims priority to U.S. Provisional Pat. App. No.62/263,102, entitled “Ultrasonic Surgical Instrument with DisposableTube Assembly and Clamp Pad,” filed Dec. 4, 2015, the disclosure ofwhich is incorporated by reference herein.

This application also claims priority to U.S. Provisional Pat. App. No.62/329,381, entitled “Apparatus to Provide Reusability of UltrasonicSurgical Instrument Feature,” filed Apr. 29, 2016, the disclosure ofwhich is incorporated by reference herein.

BACKGROUND

Examples of ultrasonic surgical instruments include the HARMONIC ACE®Ultrasonic Shears, the HARMONIC WAVE® Ultrasonic Shears, the HARMONICFOCUS® Ultrasonic Shears, and the HARMONIC SYNERGY® Ultrasonic Blades,all by Ethicon Endo-Surgery, Inc. of Cincinnati, Ohio. Further examplesof such devices and related concepts are disclosed in U.S. Pat. No.5,322,055, entitled “Clamp Coagulator/Cutting System for UltrasonicSurgical Instruments,” issued Jun. 21, 1994, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 5,873,873, entitled“Ultrasonic Clamp Coagulator Apparatus Having Improved Clamp Mechanism,”issued Feb. 23, 1999, the disclosure of which is incorporated byreference herein; U.S. Pat. No. 5,980,510, entitled “Ultrasonic ClampCoagulator Apparatus Having Improved Clamp Arm Pivot Mount,” filed Oct.10, 1997, the disclosure of which is incorporated by reference herein;U.S. Pat. No. 6,325,811, entitled “Blades with Functional BalanceAsymmetries for use with Ultrasonic Surgical Instruments,” issued Dec.4, 2001, the disclosure of which is incorporated by reference herein;U.S. Pat. No. 6,773,444, entitled “Blades with Functional BalanceAsymmetries for Use with Ultrasonic Surgical Instruments,” issued Aug.10, 2004, the disclosure of which is incorporated by reference herein;U.S. Pat. No. 6,783,524, entitled “Robotic Surgical Tool with UltrasoundCauterizing and Cutting Instrument,” issued Aug. 31, 2004, thedisclosure of which is incorporated by reference herein; U.S. Pat. No.8,461,744, entitled “Rotating Transducer Mount for Ultrasonic SurgicalInstruments,” issued Jun. 11, 2013, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 8,591,536, entitled“Ultrasonic Surgical Instrument Blades,” issued Nov. 26, 2013, thedisclosure of which is incorporated by reference herein; and U.S. Pat.No. 8,623,027, entitled “Ergonomic Surgical Instruments,” issued Jan. 7,2014, the disclosure of which is incorporated by reference herein.

Still further examples of ultrasonic surgical instruments are disclosedin U.S. Pub. No. 2006/0079874, entitled “Tissue Pad for Use with anUltrasonic Surgical Instrument,” published Apr. 13, 2006, now abandoned,the disclosure of which is incorporated by reference herein; U.S. Pub.No. 2007/0191713, entitled “Ultrasonic Device for Cutting andCoagulating,” published Aug. 16, 2007, now abandoned, the disclosure ofwhich is incorporated by reference herein; U.S. Pub. No. 2007/0282333,entitled “Ultrasonic Waveguide and Blade,” published Dec. 6, 2007, nowabandoned, the disclosure of which is incorporated by reference herein;U.S. Pub. No. 2008/0200940, entitled “Ultrasonic Device for Cutting andCoagulating,” published Aug. 21, 2008, now abandoned, the disclosure ofwhich is incorporated by reference herein; and U.S. Pub. No.2010/0069940, entitled “Ultrasonic Device for Fingertip Control,”published Mar. 18, 2010, now U.S. Pat. No. 9,023,071, issued May 5,2015, the disclosure of which is incorporated by reference herein.

Some ultrasonic surgical instruments may include a cordless transducersuch as that disclosed in U.S. Pub. No. 2012/0112687, entitled “RechargeSystem for Medical Devices,” published May 10, 2012, now U.S. Pat. No.9,381,058, issued Jul. 5, 2016, the disclosure of which is incorporatedby reference herein; U.S. Pub. No. 2012/0116265, entitled “SurgicalInstrument with Charging Devices,” published May 10, 2012, nowabandoned, the disclosure of which is incorporated by reference herein;and/or U.S. Pat. App. No. 61/410,603, filed Nov. 5, 2010, entitled“Energy-Based Surgical Instruments,” the disclosure of which isincorporated by reference herein.

Additionally, some ultrasonic surgical instruments may include anarticulating shaft section and/or a bendable ultrasonic waveguide.Examples of such ultrasonic surgical instruments are disclosed in U.S.Pat. No. 5,897,523, entitled “Articulating Ultrasonic SurgicalInstrument,” issued Apr. 27, 1999, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 5,989,264, entitled“Ultrasonic Polyp Snare,” issued Nov. 23, 1999, the disclosure of whichis incorporated by reference herein; U.S. Pat. No. 6,063,098, entitled“Articulable Ultrasonic Surgical Apparatus,” issued May 16, 2000, thedisclosure of which is incorporated by reference herein; U.S. Pat. No.6,090,120, entitled “Articulating Ultrasonic Surgical Instrument,”issued Jul. 18, 2000, the disclosure of which is incorporated byreference herein; U.S. Pat. No. 6,454,782, entitled “Actuation Mechanismfor Surgical Instruments,” issued Sep. 24, 2002, the disclosure of whichis incorporated by reference herein; U.S. Pat. No. 6,589,200, entitled“Articulating Ultrasonic Surgical Shears,” issued Jul. 8, 2003, thedisclosure of which is incorporated by reference herein; U.S. Pat. No.6,752,815, entitled “Method and Waveguides for Changing the Direction ofLongitudinal Vibrations,” issued Jun. 22, 2004, the disclosure of whichis incorporated by reference herein; U.S. Pat. No. 7,135,030, entitled“Articulating Ultrasonic Surgical Shears,” issued Nov. 14, 2006; U.S.Pat. No. 7,621,930, entitled “Ultrasound Medical Instrument Having aMedical Ultrasonic Blade,” issued Nov. 24, 2009, the disclosure of whichis incorporated by reference herein; U.S. Pub. No. 2014/0005701,published Jan. 2, 2014, issued as U.S. Pat. No. 9,393,037 on Jul. 19,2016, entitled “Surgical Instruments with Articulating Shafts,” now U.S.Pat. No. 9,393,037, issued Jul. 19 2016 the disclosure of which isincorporated by reference herein; U.S. Pub. No. 2014/0005703, entitled“Surgical Instruments with Articulating Shafts,” published Jan. 2, 2014,issued as U.S. Pat. No. 9,408,622 on Aug. 9, 2016, the disclosure ofwhich is incorporated by reference herein; U.S. Pub. No. 2014/0114334,entitled “Flexible Harmonic Waveguides/Blades for Surgical Instruments,”published Apr. 24, 2014, issued as U.S. Pat. No. 9,095,367 on Aug. 4,2015, the disclosure of which is incorporated by reference herein; U.S.Pub. No. 2015/0080924, entitled “Articulation Features for UltrasonicSurgical Instrument,” published Mar. 19, 2015, issued as U.S. Pat. No.10,172,636 on Jan. 8, 2019, the disclosure of which is incorporated byreference herein; and U.S. Pat. App. No. 14/258,179, now 62/176,880,entitled “Ultrasonic Surgical Device with Articulating End Effector,”filed Apr. 22, 2014, the disclosure of which is incorporated byreference herein.

While several surgical instruments and systems have been made and used,it is believed that no one prior to the inventors has made or used theinvention described in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim this technology, it is believed this technologywill be better understood from the following description of certainexamples taken in conjunction with the accompanying drawings, in whichlike reference numerals identify the same elements and in which:

FIG. 1 depicts a side elevational view of an exemplary ultrasonicsurgical instrument;

FIG. 2 depicts a perspective view of the instrument of FIG. 1;

FIG. 3 depicts a perspective view of the instrument of FIG. 1, with adisposable portion separated from a reusable portion;

FIG. 4 depicts a perspective view of an end effector of the instrumentof FIG. 1, in an open configuration;

FIG. 5 depicts a partially exploded view of the end effector of FIG. 4;

FIG. 6A depicts a side elevational view of the end effector of FIG. 4,in the open configuration;

FIG. 6B depicts a side elevational view of the end effector of FIG. 4,in a closed configuration;

FIG. 7 depicts a side cross-sectional view of the end effector of FIG.4, in the open configuration;

FIG. 8 depicts a perspective view of an exemplary alternative disposableportion of an ultrasonic surgical instrument that may be used with avariation of the reusable portion of the instrument of FIG. 1;

FIG. 9 depicts another perspective view of the disposable portion ofFIG. 8:

FIG. 10A depicts a side elevational view of the disposable portion ofFIG. 8, with a portion of the shaft assembly omitted, and with the endeffector in an open configuration:

FIG. 10B depicts a side elevational view of the disposable portion ofFIG. 8, with a portion of the shaft assembly omitted, and with the endeffector in a closed configuration;

FIG. 11 depicts an exploded view of the disposable portion of FIG. 8,with a first disposable sub-assembly separated from a second disposablesub-assembly;

FIG. 12 depicts an exploded view of the distal end of the firstdisposable sub-assembly of FIG. 11;

FIG. 13 depicts a perspective view of a clamp arm of the firstdisposable sub-assembly of FIG. 11;

FIG. 14 depicts another perspective view of the clamp arm of FIG. 13;

FIG. 15 depicts a top plan view of a distal inner tube member of thefirst disposable sub-assembly of FIG. 11;

FIG. 16 depicts a side elevational view of the distal inner tube memberof FIG. 15;

FIG. 17 depicts a perspective view of the distal inner tube member ofFIG. 15;

FIG. 18 depicts another perspective view of the distal inner tube memberof FIG. 15;

FIG. 19 depicts a perspective view of the distal end of an outer tube ofthe first disposable sub-assembly of FIG. 11;

FIG. 20 depicts a cross-sectional perspective view of the distal end ofthe outer tube of FIG. 19;

FIG. 21 depicts a perspective view of the proximal end of the outer tubeof FIG. 19;

FIG. 22 depicts a cross-sectional perspective view of the proximal endof the outer tube of FIG. 19;

FIG. 23 depicts a perspective view of the distal end of the seconddisposable sub-assembly of FIG. 11;

FIG. 24 depicts a top plan view of the distal end of the seconddisposable sub-assembly of FIG. 11;

FIG. 25 depicts a perspective view of the distal end of the seconddisposable sub-assembly of FIG. 11, with a portion of a proximal innertube member broken away to reveal a seal member disposed between theinner tube member and an acoustic waveguide;

FIG. 26 depicts a perspective view of the seal member of FIG. 25;

FIG. 27 depicts a cross-sectional perspective view of the seal member ofFIG. 25;

FIG. 28 depicts a perspective view of a knob member of the seconddisposable sub-assembly of FIG. 11;

FIG. 29 depicts a cross-sectional perspective view of the knob member ofFIG. 28;

FIG. 30 depicts a perspective view of an outer tube actuator of thesecond disposable sub-assembly of FIG. 11;

FIG. 31 depicts a top plan view of the outer tube actuator of FIG. 30;

FIG. 32 depicts a partial view of the disposable portion of FIG. 8,showing the outer tube of FIG. 19 extending from the knob member of FIG.28;

FIG. 33A depicts a partial view of the disposable portion of FIG. 8,showing the same components depicted in FIG. 32 but with the knob memberomitted to reveal internal components, with the first disposablesub-assembly in a distal position before a guide slot of the outer tubehas engaged a guide pin of the knob member during the process ofassembly;

FIG. 33B depicts a partial view of the disposable portion of FIG. 8,showing the same components depicted in FIG. 32 but with the knob memberomitted to reveal internal components, with the first disposablesub-assembly in a first proximal position whereby the guide pin hastraversed a first portion of a guide slot in the outer tube during theprocess of assembly;

FIG. 33C depicts a partial view of the disposable portion of FIG. 8,showing the same components depicted in FIG. 32 but with the knob memberomitted to reveal internal components, with the first disposablesub-assembly in a second proximal position whereby the guide pin hastraversed a second portion of a guide slot in the outer tube during theprocess of assembly;

FIG. 33D depicts a partial view of the disposable portion of FIG. 8,showing the same components depicted in FIG. 32 but with the knob memberomitted to reveal internal components, with the first disposablesub-assembly in a fully coupled third proximal position upon completionof the process of assembly;

FIG. 34A depicts a cross-sectional perspective view of the distal end ofthe disposable portion of FIG. 8, with the first disposable sub-assemblyin a distal position and at a first angular orientation during theprocess of assembly;

FIG. 34B depicts a cross-sectional perspective view of the distal end ofthe disposable portion of FIG. 8, with the first disposable sub-assemblyin a first proximal position and at the first angular orientation duringthe process of assembly;

FIG. 34C depicts a cross-sectional perspective view of the distal end ofthe disposable portion of FIG. 8, with the first disposable sub-assemblyin a second proximal position and at the first angular orientationduring the process of assembly;

FIG. 34D depicts a cross-sectional perspective view of the distal end ofthe disposable portion of FIG. 8, with the first disposable sub-assemblyin a third proximal position and at a second angular orientation duringthe process of assembly;

FIG. 34E depicts a cross-sectional perspective view of the distal end ofthe disposable portion of FIG. 8, with the first disposable sub-assemblyin a fourth proximal position and at the second angular orientationduring the process of assembly;

FIG. 34F depicts cross-sectional perspective view of the distal end ofthe disposable portion of FIG. 8, with the first disposable sub-assemblyin a fully coupled fifth proximal position and at the second angularorientation upon completion of the process of assembly;

FIG. 35A depicts a cross-sectional perspective view of the disposableportion of FIG. 8, with the knob member at a proximal position before aprocess of disassembly;

FIG. 35B depicts a cross-sectional perspective view of the disposableportion of FIG. 8, with the knob member at a distal position to initiatethe process of disassembly;

FIG. 35C depicts a cross-sectional perspective view of the disposableportion of FIG. 8, with cantilevered buttons of the knob member pressedinwardly during the process of disassembly;

FIG. 35D depicts a cross-sectional perspective view of the disposableportion of FIG. 8, with the first disposable sub-assembly slid distallyduring the process of disassembly;

FIG. 35E depicts a cross-sectional perspective view of the disposableportion of FIG. 8, with the first disposable sub-assembly removed fromthe second disposable sub-assembly upon completion of the process ofdisassembly;

FIG. 36A depicts a cross-sectional top view of portions of the shaftassembly of the disposable portion of FIG. 8, with the outer tube in aproximal position before the process of disassembly;

FIG. 36B depicts a cross-sectional top view of portions of the shaftassembly of the disposable portion of FIG. 8, with the outer tube in adistal position during the process of disassembly;

FIG. 37 depicts a perspective view of an alternative ultrasonic surgicalinstrument having a disposable assembly and a reusable assembly;

FIG. 38 depicts a partially exploded view of the ultrasonic surgicalinstrument of FIG. 37, with a first disposable sub-assembly separatedfrom a second disposable sub-assembly;

FIG. 39 depicts a perspective view of an end effector of the ultrasonicsurgical instrument of FIG. 37, in an open configuration;

FIG. 40 depicts a perspective exploded view of the distal end of thefirst disposable sub-assembly of FIG. 38;

FIG. 41 depicts a perspective view of a distal inner tube member of thefirst disposable sub-assembly of FIG. 38;

FIG. 42 depicts a bottom plan view of the distal inner tube member ofFIG. 41;

FIG. 43 depicts a perspective front view of the proximal end of thefirst disposable sub-assembly of FIG. 38;

FIG. 44 depicts a perspective rear view of the proximal end of the firstdisposable sub-assembly of FIG. 38;

FIG. 45 depicts a perspective view of the distal end of the seconddisposable sub-assembly of FIG. 38;

FIG. 46 depicts a perspective view of the proximal end of the seconddisposable sub-assembly of FIG. 38;

FIG. 47 depicts an exploded perspective view of the proximal end of thesecond disposable sub-assembly of FIG. 38;

FIG. 48 depicts a perspective view of a knob member of the seconddisposable sub-assembly of FIG. 38;

FIG. 49 depicts a cross-sectional perspective view of the knob member ofFIG. 48, taken along line 49-49 of FIG. 48;

FIG. 50 depicts a perspective view of a tube actuator of the seconddisposable sub-assembly of FIG. 38;

FIG. 51 depicts a perspective front view of an assembly tool that may beutilized to assemble the reusable assembly of FIG. 37 with thedisposable assembly of FIG. 37, as well as assemble the first disposablesub-assembly of FIG. 38 with the second disposable sub-assembly of FIG.38;

FIG. 52 depicts a perspective rear view of the assembly tool of FIG. 51;

FIG. 53 depicts an exploded front perspective view of the assembly toolof FIG. 51;

FIG. 54 depicts an exploded rear perspective view of the assembly toolof FIG. 51;

FIG. 55A depicts a perspective view of the proximal end of the firstsub-assembly of FIG. 38 being coupled with the proximal end of thesecond sub-assembly of FIG. 38, where the proximal end of the firstsub-assembly is distal in relation to the knob member of the secondsub-assembly;

FIG. 55B depicts a perspective view of the proximal end of the firstsub-assembly of FIG. 38 being coupled with the proximal end of thesecond sub-assembly of FIG. 38, where the proximal end of the firstsub-assembly is placed within the knob member of the secondsub-assembly;

FIG. 56A depicts a perspective view of the proximal end of the firstsub-assembly of FIG. 38 being coupled with the proximal end of thesecond sub-assembly of FIG. 38 with the knob member omitted for clarity,where the proximal end of the first sub-assembly is distal in relationto the knob member of the second sub-assembly;

FIG. 56B depicts a perspective view of the proximal end of the firstsub-assembly of FIG. 38 being coupled with the proximal end of thesecond sub-assembly of FIG. 38 with the knob member omitted for clarity,where the proximal end of the first sub-assembly abuts against thedistal end of the tube actuator of the second sub-assembly;

FIG. 56C depicts a perspective view of the proximal end of firstsub-assembly of FIG. 38 being coupled with the proximal end of thesecond sub-assembly of FIG. 38 with the knob member omitted for clarity,where the proximal end of the first sub-assembly is within the tubeactuator of the second sub-assembly without being coupled with the tubeactuator of the second sub-assembly;

FIG. 56D depicts a perspective view of the proximal end of the firstsub-assembly of FIG. 38 being coupled with the proximal end of thesecond sub-assembly of FIG. 38 with the knob member omitted for clarity,where the proximal end of the first sub-assembly is fully coupled withthe tube actuator of the second sub-assembly;

FIG. 57A depicts a cross-sectional front view of the proximal end of thefirst sub-assembly of FIG. 38 being coupled with the proximal end of thesecond sub-assembly of FIG. 38, corresponding with the view shown inFIG. 56C, with the knob member of the second sub-assembly shown, takenalong line 57-57 of FIG. 55A;

FIG. 57B depicts a cross-sectional front view of the proximal end offirst sub-assembly of FIG. 38 being coupled with the proximal end of thesecond sub-assembly of FIG. 38, corresponding with the view shown inFIG. 56D, with the knob member of the second sub-assembly shown, takenalong line 57-57 of FIG. 55A;

FIG. 58A depicts a cross-sectional perspective view of the distal end ofthe first sub-assembly of FIG. 38 being coupled with the distal end ofthe second sub-assembly of FIG. 38, where the first sub-assembly isinserted over the second sub-assembly in the proximal direction, takenalong line 58-58 of FIG. 39;

FIG. 58B depicts a cross-sectional perspective view of the distal end ofthe first sub-assembly of FIG. 38 being coupled with the distal end ofthe second sub-assembly of FIG. 38, where the first sub-assembly isfurther inserted over the second sub-assembly in the proximal direction,taken along line 58-58 of FIG. 39;

FIG. 58C depicts a cross-sectional perspective view of the distal end ofthe first sub-assembly of FIG. 38 being coupled with the distal end ofthe second sub-assembly of FIG. 38, where the first sub-assembly isfurther inserted over the second sub-assembly in the proximal direction,taken along line 58-58 of FIG. 39;

FIG. 58D depicts a cross-sectional perspective view of the distal end ofthe first sub-assembly of FIG. 38 being coupled with the distal end ofthe second sub-assembly of FIG. 38, where the first sub-assembly is inthe most proximal position, taken along 58-58 of FIG. 39;

FIG. 58E depicts a cross-sectional perspective view of the distal end ofthe first sub-assembly of FIG. 38 being coupled with the distal end ofthe second sub-assembly of FIG. 38, where the second sub-assembly isrotated in order to fully couple with the first sub-assembly;

FIG. 59A depicts a perspective view of the distal end of the firstsub-assembly of FIG. 38 being coupled with the distal end of the secondsub-assembly of FIG. 38 with an outer tube of the first sub-assemblyomitted for clarity, where the first sub-assembly is inserted over thesecond sub-assembly in the proximal direction;

FIG. 59B depicts a perspective view of the distal end of the firstsub-assembly of FIG. 38 being coupled with the distal end of the secondsub-assembly of FIG. 38 with an outer tube of the first sub-assemblyomitted for clarity, where the first sub-assembly is further insertedover the second sub-assembly in the proximal direction;

FIG. 59C depicts a perspective view of the distal end of the firstsub-assembly of FIG. 38 being coupled with the distal end of the secondsub-assembly of FIG. 38 with an outer tube of the first sub-assemblyomitted for clarity, where the first sub-assembly is rotated 90 degreesto fully couple with the second sub-assembly;

FIG. 60A depicts a perspective view of the first sub-assembly of FIG. 38being coupled with the second sub-assembly of FIG. 38 utilizing theassembly tool of FIG. 51, with the first sub-assembly and the assemblytool being positioned at a first angular orientation;

FIG. 60B depicts a perspective view of the first sub-assembly of FIG. 38being coupled with the second sub-assembly of FIG. 38 utilizing theassembly tool of FIG. 51, with the first sub-assembly and the assemblytool being positioned at a second angular orientation to fully couplethe first sub-assembly tool with the tube actuator of the secondsub-assembly;

FIG. 61A depicts a front cross-sectional view of the proximal end of thefirst and second sub-assemblies of FIG. 38, taken along line 61-61 ofFIG. 55A;

FIG. 61B depicts a front cross-sectional view of the proximal end of thefirst sub-assembly of FIG. 38 decoupled from the proximal end of thesecond sub-assembly of FIG. 38, taken along line 61-61 of FIG. 55A;

FIG. 62A depicts a front cross-sectional view of the distal end of thefirst and second sub-assemblies of FIG. 38, taken along line 62-62 ofFIG. 39;

FIG. 62B depicts a front cross-sectional view of the distal end of thefirst sub-assembly of FIG. 38 rotating relative to the distal end of thesecond sub-assembly of FIG. 38, taken along line 62-62 of FIG. 39;

FIG. 62C depicts a front cross-sectional view of the distal end of thefirst sub-assembly of FIG. 38 decoupled with the distal end of thesecond sub-assembly of FIG. 38, taken along line 62-62 of FIG. 39;

FIG. 63A depicts a side elevation view of the reusable assembly of FIG.37 decoupled from the disposable assembly of FIG. 37;

FIG. 63B depicts a side elevation view of the reusable assembly of FIG.37 coupled with the disposable assembly of FIG. 37;

FIG. 64A depicts a perspective view of the assembly tool of FIG. 51utilized to couple the reusable assembly of FIG. 37 with the disposableassembly of FIG. 37, where the reusable assembly is decoupled with thedisposable assembly, where the assembly tool is distal in relation tothe knob member of the second sub-assembly of FIG. 38;

FIG. 64B depicts a perspective view of the assembly tool of FIG. 51utilized to couple the reusable assembly of FIG. 37 with the disposableassembly of FIG. 37, where the reusable assembly is decoupled with thedisposable assembly, where the assembly tool is rotationally secured tothe knob member of the second sub-assembly of FIG. 38;

FIG. 64C depicts a perspective view of the assembly tool of FIG. 51utilized to couple the reusable assembly of FIG. 37 with the disposableassembly of FIG. 37, where the reusable assembly is coupled with thedisposable assembly, where the assembly tool is rotationally secured tothe knob member of the second sub-assembly of FIG. 38;

FIG. 65A depicts a top plan view of the assembly tool of FIG. 51rotationally secured to the knob member of the second sub-assembly ofFIG. 38, where the reusable assembly of FIG. 37 is sufficiently coupledwith the disposable assembly of FIG. 37;

FIG. 65B depicts a top plan view of the assembly tool of FIG. 51rotationally secured to the knob member of the second sub-assembly ofFIG. 38, where the reusable assembly of FIG. 37 is sufficiently coupledwith the disposable assembly of FIG. 37 and the reusable assembly isfurther rotated relative to the disposable assembly;

FIG. 65C depicts a top plan view of the assembly tool of FIG. 51rotationally secured to the knob member of the second sub-assembly ofFIG. 38, where the reusable assembly of FIG. 37 is sufficiently coupledwith the disposable assembly of FIG. 37 and the reusable assembly isfurther rotated relative to the disposable assembly;

FIG. 66 depicts a perspective view of another alternative ultrasonicsurgical instrument having a disposable assembly and a reusableassembly;

FIG. 67 depicts a partially exploded view of the ultrasonic surgicalinstrument of FIG. 66, with a first disposable sub-assembly separatedfrom a second disposable sub-assembly;

FIG. 68 depicts a perspective view of an end effector of the ultrasonicsurgical instrument of FIG. 66;

FIG. 69 depicts a perspective exploded view of the first disposablesub-assembly of FIG. 67 and the distal end of the second disposablesub-assembly of FIG. 67;

FIG. 70 depicts a perspective exploded view of the first disposablesub-assembly of FIG. 67;

FIG. 71 depicts a top plan view of a distal inner tube member of thefirst disposable sub-assembly of FIG. 67;

FIG. 72 depicts a side elevational view of the distal inner tube memberof FIG. 71;

FIG. 73 depicts a bottom plan view of the distal inner tube member ofFIG. 71;

FIG. 74 depicts a perspective view of a distal outer tube member of thefirst disposable sub-assembly of FIG. 67;

FIG. 75 depicts cross-sectional perspective view of the distal outertube member of FIG. 74;

FIG. 76 depicts a perspective view of the distal end of the seconddisposable sub-assembly of FIG. 67;

FIG. 77 depicts a perspective view of a coupling feature of the distalend of the second disposable subassembly of FIG. 67;

FIG. 78A depicts a perspective view of an assembly tool that may beutilized to assemble the reusable assembly of FIG. 66 with thedisposable assembly of FIG. 66, as well as assemble the first disposablesub-assembly of FIG. 67 and the second disposable sub-assembly of FIG.67, where the assembly tool is in an open configuration;

FIG. 78B depicts another perspective view of the assembly tool of FIG.78A, where the assembly tool is in a closed configuration;

FIG. 79 depicts a perspective view of the assembly tool of FIG. 78A;

FIG. 80 depicts a perspective exploded view of the assembly tool of FIG.78A;

FIG. 81 depicts a perspective view of a base member of the assembly toolof FIG. 78A;

FIG. 82 depicts a cross-sectional side view of the base member of FIG.81, taken along line 82-82 of FIG. 81;

FIG. 83 depicts cross-sectional perspective view of the base member ofFIG. 81, taken along line 83-83 of FIG. 81;

FIG. 84 depicts a cross-sectional perspective view of the base member ofFIG. 81, taken along line 84-84 of FIG. 81;

FIG. 85 depicts a front perspective view of a rotating member of theassembly tool of FIG. 78A;

FIG. 86 depicts a rear perspective view of the rotating member of FIG.85;

FIG. 87A depicts a cross-sectional perspective view of the assembly toolof FIG. 78A in an open configuration, taken along line 87A-87A of FIG.78A;

FIG. 87B depicts a cross-sectional perspective view of the assembly toolof FIG. 78A in a closed configuration, taken along line 87B-87B of FIG.78B;

FIG. 88A depicts a cross-sectional side view of the assembly tool ofFIG. 78A in an open configuration to receive the first disposablesub-assembly of FIG. 67, taken along line 87A-87A of FIG. 78A;

FIG. 88B depicts a cross-sectional side view of the assembly tool ofFIG. 78A in an open configuration housing the first disposablesub-assembly of FIG. 67, taken along line 87A-87A of FIG. 78A;

FIG. 88C depicts a cross-sectional side view of the assembly tool ofFIG. 78A in a closed configuration fixing the first disposablesub-assembly of FIG. 67 relative to the assembly tool, taken along line87B-87B of FIG. 78B;

FIG. 89A depicts a cross-sectional perspective view of the assembly toolof FIG. 78A in an open configuration to receive the first disposablesub-assembly of FIG. 67, taken along line 87A-87A of FIG. 78A;

FIG. 89B depicts a cross-sectional perspective view of the assembly toolof FIG. 78A in an open configuration housing the first disposablesub-assembly of FIG. 67, taken along line 87A-87A of FIG. 78A;

FIG. 89C depicts a cross-sectional perspective view of the assembly toolof FIG. 78A in a closed configuration fixing the first disposablesub-assembly of FIG. 67 relative to the assembly tool, taken along line87B-87B of FIG. 78B:

FIG. 90 depicts a perspective view of an alternative assembly tool thatmay be utilized to assemble the first disposable sub-assembly of FIG. 67and the second disposable sub-assembly of FIG. 67, where the assemblytool is in a closed configuration;

FIG. 91 depicts a perspective view of the assembly tool of FIG. 90 in anopen configuration;

FIG. 92 depicts a side elevational view of the assembly tool of FIG. 90in a closed position and fixed to the first disposable sub-assembly ofFIG. 67;

FIG. 93 depicts a cross-sectional rear view, taken along line 93-93 ofFIG. 92, where the assembly tool of FIG. 90 is in a closed position andfixed to the first disposable sub-assembly of FIG. 67;

FIG. 94A depicts a side elevational view of the first sub-assembly ofFIG. 67 right before being inserted over the distal end of the secondsub-assembly of FIG. 67;

FIG. 94B depicts a side elevational view of the first sub-assembly ofFIG. 67 partially inserted over the distal end of the secondsub-assembly of FIG. 67;

FIG. 94C depicts a side elevational view of the first sub-assembly ofFIG. 67 inserted to a most proximal position over the distal end of thesecond sub-assembly of FIG. 67;

FIG. 94D depicts a side elevational view of the first sub-assembly ofFIG. 67 inserted to a most proximal position over the distal end of thesecond sub-assembly of FIG. 67, where the second sub-assembly is rotatedrelative to the first sub-assembly such that the first sub-assembly iscoupled to the second sub-assembly;

FIG. 95A depicts a perspective view of the first sub-assembly of FIG. 67inserted over the distal end of the second sub-assembly of FIG. 67,where the distal outer tube member of the first sub-assembly is shown inphantom for clarity;

FIG. 95B depicts a perspective view of the first sub-assembly of FIG. 67further inserted to a most proximal position over the distal end of thesecond sub-assembly of FIG. 67, where the distal outer tube member ofthe first sub-assembly is omitted for clarity;

FIG. 95C depicts a perspective view of the first sub-assembly of FIG. 67inserted to a most proximal position over the distal end of the secondsub-assembly of FIG. 67, where the first sub-assembly is rotatedrelative to the second sub-assembly, where the distal outer tube memberof the first sub-assembly is omitted for clarity;

FIG. 95D depicts a perspective view of the first sub-assembly of FIG. 67inserted to a most proximal position over the distal end of the secondsub-assembly of FIG. 67, where the second sub-assembly is rotatedrelative to the second sub-assembly such that the first sub-assembly iscoupled to the second sub-assembly;

FIG. 96A depicts a perspective view of the assembly tool of FIG. 78Autilized to couple the reusable assembly of FIG. 66 with the disposableassembly of FIG. 66, with a housing portion of the reusable assemblyomitted for clarity, where the reusable assembly is decoupled with thedisposable assembly, where the assembly tool is distal in relation tothe knob member of the second sub-assembly of FIG. 67;

FIG. 96B depicts a perspective view of the assembly tool of FIG. 78Autilized to couple the reusable assembly of FIG. 66 with the disposableassembly of FIG. 66, with a housing portion of the reusable assemblyomitted for clarity, where the reusable assembly is decoupled with thedisposable assembly, where the assembly tool is rotationally secured tothe knob member of the second sub-assembly of FIG. 67;

FIG. 96C depicts a perspective view of the assembly tool of FIG. 78Autilized to couple the reusable assembly of FIG. 66 with the disposableassembly of FIG. 66, with a housing portion of the reusable assemblyomitted for clarity, where the reusable assembly is coupled with thedisposable assembly, where the assembly tool is rotationally secured tothe knob member of the second sub-assembly of FIG. 67;

FIG. 97A depicts a cross-sectional rear view of the assembly tool ofFIG. 78A rotationally secured to the knob member of the secondsub-assembly of FIG. 67, where the reusable assembly of FIG. 66 issufficiently coupled with the disposable assembly of FIG. 66, takenalong line 97-97 of FIG. 96C;

FIG. 97B depicts a cross-sectional rear view of the assembly tool ofFIG. 78A rotationally secured to the knob member of the secondsub-assembly of FIG. 67, where the reusable assembly of FIG. 66 issufficiently coupled with the disposable assembly of FIG. 66 and thereusable assembly is further rotated relative to the disposableassembly, taken along line 97-97 of FIG. 96C;

FIG. 97C depicts a cross-sectional rear view of the assembly tool ofFIG. 78A rotationally secured to the knob member of the secondsub-assembly of FIG. 67, where the reusable assembly of FIG. 66 issufficiently coupled with the disposable assembly of FIG. 66 and thereusable assembly is further rotated relative to the disposableassembly, taken along line 97-97 of FIG. 96C;

FIG. 97D depicts a cross-sectional rear view of the assembly tool ofFIG. 78A rotationally secured to the knob member of the secondsub-assembly of FIG. 67, where the reusable assembly of FIG. 66 issufficiently coupled with the disposable assembly of FIG. 66 and thereusable assembly is further rotated relative to the disposableassembly, taken along line 97-97 of FIG. 96C;

FIG. 98 depicts a perspective view of another alternative ultrasonicsurgical instrument having a disposable assembly and a reusableassembly;

FIG. 99 depicts a partially exploded view of the ultrasonic surgicalinstrument of FIG. 98, with a first disposable sub-assembly separatedfrom a second disposable sub-assembly;

FIG. 100 depicts a partial perspective view of the distal portion of ahandle assembly of the ultrasonic surgical instrument of FIG. 98 and theproximal portion of a shaft assembly of the ultrasonic surgicalinstrument of FIG. 98;

FIG. 101 depicts a perspective view of a knob member of the handleassembly of FIG. 100;

FIG. 102 depicts another perspective view of the knob member of FIG.101;

FIG. 103 depicts a perspective view of a coupling feature of a firstdisposable sub-assembly of the disposable assembly of FIG. 98;

FIG. 104 depicts another perspective view of the coupling feature ofFIG. 103;

FIG. 105 depicts a perspective view of a coupling feature of the handleassembly of FIG. 100;

FIG. 106 depicts a partial perspective view of the coupling feature ofFIG. 105;

FIG. 107A depicts a partial perspective view of the distal portion ofthe handle assembly of FIG. 100 and the proximal portion of the shaftassembly of FIG. 100, with the knob member of FIG. 101 omitted, and withthe first disposable sub-assembly of FIG. 98 at a first longitudinalposition and at a first angular position;

FIG. 107B depicts a partial perspective view of the distal portion ofthe handle assembly of FIG. 100 and the proximal portion of the shaftassembly of FIG. 100, with the knob member of FIG. 101 omitted, and withthe first disposable sub-assembly of FIG. 98 at a second longitudinalposition and at the first angular position;

FIG. 107C depicts a partial perspective view of the distal portion ofthe handle assembly of FIG. 100 and the proximal portion of the shaftassembly of FIG. 100, with the knob member of FIG. 101 omitted, and withthe first disposable sub-assembly of FIG. 98 at a third longitudinalposition and at the first angular position;

FIG. 107D depicts a partial perspective view of the distal portion ofthe handle assembly of FIG. 100 and the proximal portion of the shaftassembly of FIG. 100, with the knob member of FIG. 101 omitted, and withthe first disposable sub-assembly of FIG. 98 at the third longitudinalposition and at a second angular position;

FIG. 107E depicts a partial perspective view of the distal portion ofthe handle assembly of FIG. 100 and the proximal portion of the shaftassembly of FIG. 100, with the knob member of FIG. 101 omitted, and withthe first disposable sub-assembly of FIG. 98 at the third longitudinalposition and at a third angular position;

FIG. 108 depicts a partial exploded view of the distal portion of theshaft assembly of FIG. 100, with the first disposable sub-assembly ofFIG. 98 at a distal position, and with portions of an outer tubeomitted;

FIG. 109 depicts a partial view of the distal portion of the shaftassembly of FIG. 100, with the first disposable sub-assembly of FIG. 98at a proximal position, and with portions of the outer tube omitted;

FIG. 110 depicts a perspective view of a distal inner tube member of thefirst disposable sub-assembly of FIG. 98;

FIG. 111 depicts another perspective view of the distal inner tubemember of FIG. 110;

FIG. 112 depicts a cross-sectional view of the distal inner tube memberof FIG. 110, taken along line 112-112 of FIG. 111;

FIG. 113 depicts a partial perspective view of a distal end of aproximal inner tube member of the first disposable sub-assembly of FIG.98; and

FIG. 114 depicts a partial view of the distal end of the shaft assemblyof FIG. 100, with the outer tube omitted, and with the proximal innertube member of FIG. 113 shown in broken lines.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the technology may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presenttechnology, and together with the description serve to explain theprinciples of the technology; it being understood, however, that thistechnology is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the technology shouldnot be used to limit its scope. Other examples, features, aspects,embodiments, and advantages of the technology will become apparent tothose skilled in the art from the following description, which is by wayof illustration, one of the best modes contemplated for carrying out thetechnology. As will be realized, the technology described herein iscapable of other different and obvious aspects, all without departingfrom the technology. Accordingly, the drawings and descriptions shouldbe regarded as illustrative in nature and not restrictive.

It is further understood that any one or more of the teachings,expressions, embodiments, examples, etc. described herein may becombined with any one or more of the other teachings, expressions,embodiments, examples, etc. that are described herein. Thefollowing-described teachings, expressions, embodiments, examples, etc.should therefore not be viewed in isolation relative to each other.Various suitable ways in which the teachings herein may be combined willbe readily apparent to those of ordinary skill in the art in view of theteachings herein. Such modifications and variations are intended to beincluded within the scope of the claims.

For clarity of disclosure, the terms “proximal” and “distal” are definedherein relative to a human or robotic operator of the surgicalinstrument. The term “proximal” refers the position of an element closerto the human or robotic operator of the surgical instrument and furtheraway from the surgical end effector of the surgical instrument. The term“distal” refers to the position of an element closer to the surgical endeffector of the surgical instrument and further away from the human orrobotic operator of the surgical instrument.

I. Overview of Exemplary Ultrasonic Surgical Instrument

FIGS. 1-3 show an exemplary ultrasonic surgical instrument (10) that isconfigured to be used in minimally invasive surgical procedures (e.g.,via a trocar or other small diameter access port, etc.). As will bedescribed in greater detail below, instrument (10) is operable to cuttissue and seal or weld tissue (e.g., a blood vessel, etc.)substantially simultaneously. Instrument (10) of this example comprisesa disposable assembly (100) and a reusable assembly (200). The distalportion of reusable assembly (200) is configured to removably receivethe proximal portion of disposable assembly (100), as seen in FIGS. 2-3,to form instrument (10).

In an exemplary use, assemblies (100, 200) are coupled together to forminstrument (10) before a surgical procedure, the assembled instrument(10) is used to perform the surgical procedure, and then assemblies(100, 200) are decoupled from each other for further processing. In someinstances, after the surgical procedure is complete, disposable assembly(100) is immediately disposed of while reusable assembly (200) issterilized and otherwise processed for re-use. By way of example only,reusable assembly (200) may be sterilized in a conventional relativelylow temperature, relatively low pressure, hydrogen peroxidesterilization process. Alternatively, reusable assembly (200) may besterilized using any other suitable systems and techniques (e.g.,autoclave, etc.). In some versions, reusable assembly (200) may besterilized and reused approximately 100 times. Alternatively, reusableassembly (200) may be subject to any other suitable life cycle. Forinstance, reusable assembly (200) may be disposed of after a single use,if desired. While disposable assembly (100) is referred to herein asbeing “disposable,” it should be understood that, in some instances,disposable assembly (100) may also be sterilized and otherwise processedfor re-use. By way of example only, disposable assembly (100) may besterilized and reused approximately 2-30 times, using any suitablesystems and techniques. Alternatively, disposable assembly (100) may besubject to any other suitable life cycle.

In some versions, disposable assembly (100) and/or reusable assembly(200) includes one or more features that are operable to track usage ofthe corresponding assembly (100, 200), and selectively restrictoperability of the corresponding assembly (100, 200) based on use. Forinstance, disposable assembly (100) and/or reusable assembly (200) mayinclude one or more counting sensors and a control logic (e.g.,microprocessor, etc.) that is in communication with the countingsensor(s). The counting sensor(s) may be able to detect the number oftimes the ultrasonic transducer of instrument (10) is activated, thenumber of surgical procedures the corresponding assembly (100, 200) isused in, the number of trigger closures, and/or any other suitableconditions associated with use. The control logic may track data fromthe counting sensor(s) and compare the data to one or more thresholdvalues. When the control logic determines that one or more thresholdvalues have been exceeded, the control logic may execute a controlalgorithm to disable operability of one or more components in thecorresponding assembly (100, 200). In instances where the control logicstores two or more threshold values (e.g., a first threshold for numberof activations and a second threshold for number of surgical procedures,etc.), the control logic may disable operability of one or morecomponents in the corresponding assembly (100, 200) the first time oneof those thresholds is exceeded, or on some other basis.

In versions where a control logic is operable to disable instrument (10)based on the amount of use, the control logic may also determine whetherinstrument (10) is currently being used in a surgical procedure, andrefrain from disabling instrument (10) until that particular surgicalprocedure is complete. In other words, the control logic may allow theoperator to complete the current surgical procedure but preventinstrument (10) from being used in a subsequent surgical procedure.Various suitable forms that counters or other sensors may take will beapparent to those of ordinary skill in the art in view of the teachingsherein. Various suitable forms that a control logic may take will alsobe apparent to those of ordinary skill in the art in view of theteachings herein. Similarly, various suitable control algorithms thatmay be used to restrict usage of instrument (10) will be apparent tothose of ordinary skill in the art in view of the teachings herein. Ofcourse, some versions of instrument (10) may simply omit features thattrack and/or restrict the amount of usage of instrument (10).

Disposable assembly (100) of the present example comprises a bodyportion (110), a shaft assembly (150) extending distally from bodyportion (110), and an end effector (180) located at the distal end ofshaft assembly (150). As best seen in FIGS. 4-7, end effector (180) ofthis example comprises a clamp arm (182) and an ultrasonic blade (190).Clamp arm (182) includes a clamp pad (184), which faces blade (190). Asshown in FIGS. 6A-6B and as will be described in greater detail below,clamp arm (182) is pivotable toward and away from blade (190) toselectively compress tissue between clamp pad (184) and blade (190). Asseen in FIG. 7, blade (190) is an integral feature of the distal end ofan acoustic waveguide (192), which extends coaxially through tubes (152,170), and which is configured to communicate ultrasonic vibrations toblade (190) as will be described in greater detail below.

Shaft assembly (150) comprises an outer tube (152) and an inner tube(170). Outer tube (152) is operable to translate longitudinally relativeto inner tube (170) to selectively pivot clamp arm (182) toward and awayfrom blade (190). To accomplish this, and as best seen in FIGS. 5 and 7,integral pin features (186) of clamp arm (182) pivotally secure a firstportion of clamp arm (182) to a distally projecting tongue (154) ofouter tube (152); while an inserted pin (188) pivotally secures a secondportion of clamp arm (182) to a distally projecting tongue (172) ofinner tube (170). Thus, as can be seen in the transition from FIG. 6A toFIG. 6B, tubes (152, 170) cooperate to pivot clamp arm (182) towardblade (190) when outer tube (152) is retracted proximally relative toinner tube (170). It should be understood that clamp arm (182) may bepivoted back away from blade (190) (e.g., from the position shown inFIG. 6B to the position shown in FIG. 6A) by translating outer tube(152) distally relative to inner tube (170), in reverse of the operationshown in FIGS. 6A-6B. In an exemplary use, clamp arm (182) may bepivoted toward blade (190) to grasp, compress, seal, and sever tissuecaptured between clamp pad (184) and blade (190). Clamp arm (182) may bepivoted away from blade (190) to release tissue from between clamp pad(184) and blade (190); and/or to perform blunt dissection of tissueengaging opposing outer surfaces of clamp arm (182) and blade (190).

Reusable assembly (200) comprises various features that are operable toactivate blade, including a battery and an ultrasonic transducer.Reusable assembly (200) further includes features that are operable tocouple the ultrasonic transducer with waveguide to thereby couple theultrasonic transducer with blade (190). In the present example, thedistal end of blade (190) is located at a position corresponding to ananti-node associated with resonant ultrasonic vibrations communicatedthrough waveguide (192), in order to tune the acoustic assembly to apreferred resonant frequency f_(o) when the acoustic assembly is notloaded by tissue. When the transducer assembly is energized, the distalend of blade (190) is configured to move longitudinally in the range of,for example, approximately 10 to 500 microns peak-to-peak, and in someinstances in the range of about 20 to about 200 microns at apredetermined vibratory frequency f_(o) of, for example, 55.5 kHz. Whenthe transducer assembly of the present example is activated, thesemechanical oscillations are transmitted through waveguide (192) to reachblade (190), thereby providing oscillation of blade (190) at theresonant ultrasonic frequency. Thus, when tissue is secured betweenblade (190) and clamp pad (184), the ultrasonic oscillation of blade(190) may simultaneously sever the tissue and denature the proteins inadjacent tissue cells, thereby providing a coagulative effect withrelatively little thermal spread. In some versions, an electricalcurrent may also be provided through blade (190) and/or clamp pad (184)to also seal the tissue.

In addition to the foregoing, disposable assembly (100) and/or reusableassembly (200) may be constructed and operable in accordance with atleast some of the teachings of U.S. Pub. No. 2015/0245850, entitled“Ultrasonic Surgical Instrument with Removable Handle Assembly,”published Sep. 3, 2015, issued as U.S. Pat. No. 10,010,340 on Jul. 3,2018, the disclosure of which is incorporated by reference herein. Inaddition, or in the alternative, disposable assembly (100) and/orreusable assembly (200) may be constructed and operable in accordancewith at least some of the teachings of U.S. Pub. No. 2016/0015419,entitled “Ultrasonic Surgical Instrument with Removable HandleAssembly,” published Jan. 21, 2016, the disclosure of which isincorporated by reference herein. Other suitable components, features,and operabilities that may be incorporated into disposable assembly(100) and/or reusable assembly (200) and variations thereof will beapparent to those of ordinary skill in the art in view of the teachingsherein.

II. Exemplary Alternative Disposable Assembly for Ultrasonic SurgicalInstrument with Removable Acoustic Waveguide

FIGS. 8-11 show an exemplary alternative disposable assembly (500) thatmay be used with a variation of reusable assembly (200). To the extentthat the following discussion omits various details of disposableassembly (500), it should be understood that disposable assembly (500)may incorporate the various details described above and/or detailsdescribed in any of the various references that are cited herein. Othersuitable details will be apparent to those of ordinary skill in the artin view of the teachings herein.

Disposable assembly (500) of the present example comprises a firstdisposable sub-assembly (502) and a second disposable sub-assembly(504). Sub-assemblies (502, 504) are configured to be coupled togetherin order to form disposable assembly (500), which may then be coupledwith a variation of reusable assembly (200) to form a completeultrasonic surgical instrument. After the ultrasonic surgical instrumentis used in a surgical procedure, disposable assembly (500) may beremoved from the variation of reusable assembly (200); and then firstdisposable sub-assembly (502) may be removed from second disposablesub-assembly (504). In some such instances, the variation of reusableassembly (200) may be cleaned, sterilized, and re-used up to 100 times(by way of example only). First disposable sub-assembly (502) may bedisposed of, such that first disposable sub-assembly (502) is only usedone single time. Second disposable sub-assembly (504) may be cleaned,sterilized, and re-used between 2 to 20 times (by way of example only).Of course, these re-use scenarios are merely illustrative examples. Itshould nevertheless be understood that the configuration of disposableassembly (500) may minimize the amount of single-use material that isdisposed of after each surgical procedure. This may reduce cost andoverall waste as compared to conventional instrumentation.

A. Exemplary First Disposable Sub-Assembly

As shown in FIGS. 8-12, first disposable sub-assembly (502) of thepresent example comprises an outer tube (580), a clamp arm (570), and adistal inner tube member (600). Clamp arm (570) is configured to form anend effector (550) with an ultrasonic blade (560), which is part ofsecond disposable sub-assembly (504) as will be described in greaterdetail below. Clamp arm (570) is pivotably coupled with outer tube (580)and with distal inner tube member (600). Outer tube (580) is configuredto translate longitudinally while distal inner tube member (600) remainsstationary, which drives clamp arm (570) to pivot between an openposition (FIG. 10A) and a closed position (FIG. 10B). In the closedposition, clamp arm (570) is operable to clamp tissue against blade(560), which may then be ultrasonically activated to sever and/or sealthe tissue as described herein and in various references cited herein.

As shown in FIGS. 12-14, clamp arm (570) of the present examplecomprises a pair of pin openings (572), a clamp pad (574), and a pair ofpivot studs (576). Pin openings (572) are configured to receive a pin(610), which is also disposed in a pin opening (602) of distal innertube member (600). Clamp pad (574) of the present example comprisespolytetrafluoroethylene (PTFE) and includes surface features (e.g.,teeth or ridges, etc.) that are configured to promote gripping oftissue. Various suitable materials and configurations that may be usedto form clamp pad (574) will be apparent to those of ordinary skill inthe art in view of the teachings herein. Pivot studs (576) are receivedin openings (586) of outer tube (580). Clamp arm (570) is pivotableabout axes defined by pivot studs (576) and by pin (610), which enablesclamp arm (570) to transition between the open position (FIG. 10A) andthe closed position (FIG. 10B) in response to translation of outer tube(580) relative to distal inner tube member (600).

As shown in FIGS. 12 and 15-18, distal inner tube member (600) of thepresent example comprises pin opening (602) and a pair of proximallyprojecting, resilient coupling arms (604). Each coupling arm (604)defines a laterally presented opening (606) and a proximally facing,obliquely angled bearing surface (607). As best seen in FIG. 15, eachcoupling arm (604) also flares outwardly. As also best seen in FIG. 16,the proximal end of distal inner tube member (600) also includes a pairof proximally facing, obliquely angled bearing surfaces (608) thatconverge proximally at a proximal-most point. As best seen in FIG. 18,distal inner tube member (600) further includes additional proximallyfacing, obliquely angled bearing surfaces (609). Bearing surfaces (607,608, 609) are all oriented to generally provide a lead-in toward a gap(601) that is defined in the underside of distal inner tube member(600). This gap (601) is configured to accommodate longitudinal travelof the distal end of ultrasonic blade (560) during assembly of firstdisposable sub-assembly (502) with second disposable sub-assembly (504),as will be described in greater detail below.

As will be also described in greater detail below, distal inner tubemember (600) is configured to be removably secured to a proximal innertube member (590) during assembly of first disposable sub-assembly (502)with second disposable sub-assembly (504). This coupling provides alongitudinal mechanical grounding for distal inner tube member (600),such that distal inner tube member (600) does not translatelongitudinally relative to other components of disposable assembly (500)when inner tube members (590, 600) are coupled together.

As shown in FIGS. 12 and 19-20, the distal end of outer tube (580) ofthe present example comprises openings (586) that pivotably receivepivot studs (576) as noted above. The distal end of outer tube (580)further includes a pair of elongate lateral openings (582) that arelocated proximal to openings (586). Openings (582) are angularly offsetfrom each other by 180° about the longitudinal axis of outer tube (580).A tab (584) is located at the proximal end of each opening (586). Eachtab (584) is directed inwardly and is substantially rigid. Inparticular, each tab (584) is rigid enough to not deform duringdisassembly of first disposable sub-assembly (502) from seconddisposable sub-assembly (504) as will be described in greater detailbelow. Outer tube (580) is slidably disposed about distal inner tubemember (600), such that outer tube (580) is operable to translatelongitudinally relative to distal inner tube member (600).

As shown in FIGS. 21-22, the proximal end of outer tube (580) of thepresent example comprises a guide slot (620) and a pair of lateralopenings (630). Guide slot (620) includes a first portion (622), asecond portion (624), and a third portion (626). First and thirdportions (622, 626) extend longitudinally while second portion (624)extends helically. First and third portions (622, 626) are angularlyoffset from each other by approximately 90° about the longitudinal axisof outer tube (580). Guide slot (620) thus has a dogleg configuration inthe present example. Other suitable forms that guide slot (620) may takewill be apparent to those of ordinary skill in the art in view of theteachings herein. Each lateral opening (630) includes a respective pairof distal and proximal flange features (632) in the present example.

As will be described in further detail below, outer tube (580) isconfigured to couple with a tube actuator (650) of second disposablesub-assembly (504) when first disposable sub-assembly (502) is coupledwith second disposable sub-assembly (504). Tube actuator (650) isconfigured to drive outer tube (580) longitudinally, to thereby driveclamp arm (570) toward and away from blade (560) as described above.

B. Exemplary Second Disposable Sub-Assembly

As shown in FIGS. 8-11, second disposable sub-assembly (504) of thepresent example comprises a partial handle assembly (510) having apivoting trigger (512), a set of buttons (514, 516), a coupling feature(518), a communication feature (519), and a knob member (520). As bestseen in FIG. 11 proximal inner tube member (590) extends distally frompartial handle assembly (510). An acoustic waveguide (562) is coaxiallydisposed in proximal inner tube member (590) and distally terminates inultrasonic blade (560). Waveguide (562) and blade (560) may beconfigured and operable just like waveguide (192) and blade (190)described above; and/or as described in any of the various referencescited herein.

Trigger (512) is operable to drive tube actuator (650) longitudinally,to thereby drive outer tube (580) longitudinally, to thereby drive clamparm (570) toward and away from blade (560), when first disposablesub-assembly (502) is coupled with second disposable sub-assembly (504).Structural features of tube actuator (650) will be described in greaterdetail below. Various suitable components that may be used to providelongitudinal movement of tube actuator (650) in response to pivotalmovement of trigger (512) will be apparent to those of ordinary skill inthe art in view of the teachings herein. By way of example only, trigger(512) may be operatively coupled with tube actuator (650) in accordancewith at least some of the teachings of U.S. Pub. No. 2015/0245850,entitled “Ultrasonic Surgical Instrument with Removable HandleAssembly,” published Sep. 3, 2015, issued as U.S. Pat. No. 10,010,340 onJul. 3, 2018, the disclosure of which is incorporated by referenceherein. In addition or in the alternative, trigger (512) may beoperatively coupled with tube actuator (650) in accordance with at leastsome of the teachings of U.S. Pub. No. 2016/0015419, entitled“Ultrasonic Surgical Instrument with Removable Handle Assembly,”published Jan. 21, 2016, the disclosure of which is incorporated byreference herein.

Buttons (514, 516) are operable to activate ultrasonic blade (560). Inparticular, buttons (514, 516) are operable to activate the ultrasonictransducer assembly in the variation of reusable assembly (200), whichin turn generates ultrasonic vibrations, which are communicated alongwaveguide (562) to reach blade (560). In some versions, button (514)activates ultrasonic blade (560) with ultrasonic energy at a first setof parameters (e.g., high power); while button (516) activatesultrasonic blade (560) with ultrasonic energy at a second set ofparameters (e.g., low power). As another merely illustrativealternative, button (514) may activate ultrasonic blade (560) withultrasonic energy; while button (516) activates end effector (550) toapply RF electrosurgical energy. Various suitable ways in which this maybe carried out, as well as various other suitable ways in which buttons(514, 516) may be configured, arranged, and operable will be apparent tothose of ordinary skill in the art in view of the teachings herein.

Coupling feature (518) is operable to couple with one or morecomplementary coupling features in the variation of reusable assembly(200) in accordance with at least some of the teachings of U.S. Pub. No.2015/0245850, issued as U.S. Pat. No. 10,010,340 on Jul. 3, 2018, and/orin accordance with at least some of the teachings of U.S. Pub. No.2016/0015419. In addition, or in the alternative, coupling feature (518)may be actuated to transition disposable assembly (500) into a cleaningmode in accordance with at least some of the teachings of U.S. Pub. No.2015/0245850, issued as U.S. Pat. No. 10,010,340 on Jul. 3, 2018, and/orin accordance with at least some of the teachings of U.S. Pub. No.2016/0015419. Various suitable components, features, and operabilitiesthat may be incorporated into and/or otherwise associated with couplingfeature (518) will be apparent to those of ordinary skill in the art inview of the teachings herein.

Communication feature (519) is operable to couple with one or morecomplementary coupling features in the variation of reusable assembly(200) in accordance with at least some of the teachings of U.S. Pub. No.2015/0245850, issued as U.S. Pat. No. 10,010,340 on Jul. 3, 2018, and/orin accordance with at least some of the teachings of U.S. Pub. No.2016/0015419. By way of example only, communication feature (519) maycomprise one or more electrical contacts that are operable to providedata communication and/or other electrical related operability whencoupled with one or more complementary coupling features in thevariation of reusable assembly (200). By way of example only, partialhandle assembly (510) may include sensors and/or various other kinds offeatures from which data may be provided to the variation of reusableassembly (200) via communication feature (519). Various suitablecomponents, features, and operabilities that may be incorporated intoand/or otherwise associated with communication feature (519) will beapparent to those of ordinary skill in the art in view of the teachingsherein.

As best seen in FIGS. 23-25, proximal inner tube member (590) isdisposed coaxially about waveguide (562) yet is radially spaced apartfrom waveguide (562) such that inner tube member (590) does not contactwaveguide (562). As best seen in FIG. 25, a seal member (640) iscoaxially interposed between the distal end of proximal inner tubemember (590) and waveguide (562). As best seen in FIGS. 26-27, sealmember (640) comprises a pair of inner ridges (642) and laterallypositioned flats (644) that complement flats formed in waveguide (562).Seal member (640) is formed of an elastomeric material and is located onwaveguide (562) at a longitudinal position corresponding to a nodeassociated with resonant ultrasonic vibrations communicated throughwaveguide (562). Seal member (640) thus provides structural supportbetween waveguide (562) and proximal inner tube member (590) withoutsubstantially interfering with ultrasonic vibrations through waveguide(562). Seal member (640) also prevents the ingress of fluids into thegap that is defined between proximal inner tube member (590) andwaveguide (562). It should be understood that a series of elastomericmembers may be interposed between proximal inner tube member (590) andwaveguide (562), at longitudinal positions corresponding to a nodesassociated with resonant ultrasonic vibrations communicated throughwaveguide (562), though such elastomeric members may be configureddifferently from seal member (640).

Proximal inner tube member (590) also comprises a pair of integral,outwardly projecting studs (592) in this example. Studs (592) areconfigured to fit in openings (606) of distal inner tube member (600),to thereby couple inner tube members (590, 600) together as will bedescribed in greater detail below.

Knob member (520) is operable to rotate the shaft assembly that isformed by waveguide (562), inner tube portions (590, 600), outer tube(580), and end effector (550) when first disposable sub-assembly (502)is coupled with second disposable sub-assembly (504). In particular,this shaft assembly is rotatable relative to partial handle assembly(510). As best seen in FIGS. 28-29, knob member (520) includes a pair ofcantilevered buttons (522). Each cantilevered button (522) includes aninwardly projecting prong (524). Buttons (522) are operable to bepressed inwardly to thereby drive prongs (524) inwardly, though buttons(522) are resiliently biased to maintain the position of prongs (524) asshown in FIG. 29. As also seen in FIG. 29, a guide pin (526) projectsinwardly within a bore (528) defined in knob member (520). Guide pin(526) is fixedly secured in knob member (520) and is configured tointeract with guide slot (620) of outer tube (580) during assembly anddisassembly of sub-assemblies (502, 504) as will be described in greaterdetail below.

As noted above, tube actuator (650) is configured to removably couplewith outer tube (580) and thereby drive outer tube (580) longitudinallyin response to pivotal motion of trigger (512). As best seen in FIGS.30-31, tube actuator (650) comprises a pair of distally projecting arms(654). Each arm (654) includes an outwardly projecting prong (656). Eachprong (656) has chamfered distal and proximal edges, which promote entryand exit of prongs (656) into and out of corresponding openings (630) ofouter tube (580) during assembly and disassembly of sub-assemblies (502,504) as will be described in greater detail below. Arms (654) areresiliently biased to assume a parallel relationship with each other asshown in FIG. 31. However, arms (654) are configured to deform inwardlyto enable entry and exit of prongs (656) into and out of correspondingopenings (630) of outer tube (580) during assembly and disassembly ofsub-assemblies (502, 504) as will be described in greater detail below.

C. Exemplary Assembly of First Disposable Sub-Assembly with SecondDisposable Sub-Assembly

FIGS. 33A-34F show various stages of assembling first disposablesub-assembly (502) with second disposable sub-assembly (504). Inparticular, FIGS. 33A-33D show various stages occurring at the proximalend of first disposable sub-assembly (502) during a process ofassembling first disposable sub-assembly (502) with second disposablesub-assembly (504); while FIGS. 34A-34F show various stages occurring atthe proximal end of first disposable sub-assembly (502) during a processof assembling first disposable sub-assembly (502) with second disposablesub-assembly (504).

FIG. 32 shows the same initial stage of assembly as is shown in FIG.33A. However, knob member (522) is omitted from FIGS. 33A-33D in orderto enable visualization of the components that would otherwise beobscured by knob member (522). It should be understood that during theprocess shown in FIGS. 33A-34F, an operator may grasp first disposablesub-assembly (502) in one hand, grasp second disposable sub-assembly(504) in the other hand, and then move first disposable sub-assembly(502) relative to second disposable sub-assembly (504) (while holdingknob member (520) stationary) in order to accomplish the process. Asshown in FIG. 33A, first disposable sub-assembly (502) is at a distalposition. At this stage, the proximal end of outer tube (580) is distalto guide pin (526). It should be noted that FIG. 33A also shows how theproximal end of proximal inner tube member (590) includes longitudinallyextending slots (594) that accommodates inwardly projecting features ofsecond disposable sub-assembly (504), such as guide pin (526) and thedistal ends of arms (654).

FIG. 33B shows a stage where first disposable sub-assembly (502) hasbeen translated proximally to a point where guide pin (526) hastraversed first portion (622) of guide channel (620) in outer tube(580). It should be understood that features at the distal ends ofsub-assemblies (502, 504) may provide the angular alignment of firstdisposable sub-assembly (502) relative to second disposable sub-assembly(504) that would be required in order for guide pin (526) tosuccessfully enter first portion (622) of guide channel (620) during thetransition to the state shown in FIG. 33B. In particular, interactionbetween the distal end of blade (560) and one or more bearing surfaces(607, 608, 609) of distal inner tube member (600) may ensure that firstdisposable sub-assembly (502) has an appropriate angular alignmentrelative to second disposable sub-assembly (504) in order for guide pin(526) to successfully enter first portion (622) of guide channel (620)during the transition to the state shown in FIG. 33B. At the stage shownin FIG. 33B, openings (630) area still distal to prongs (656).

FIG. 33C shows a stage where first disposable sub-assembly (502) hasbeen translated proximally and rotated about the longitudinal axis to apoint where guide pin (526) has traversed second portion (624) of guidechannel (620) in outer tube (580). During the transition from the stateshown in FIG. 33B to the state shown in FIG. 33C, first disposablesub-assembly (502) has rotated 90° relative to second disposablesub-assembly (504), about the longitudinal axis of outer tube (580). Atthe stage shown in FIG. 33C, openings (630) area still distal to prongs(656). However, the flared proximal end of outer tube (580) has justengaged the distal edges of prongs (656).

FIG. 33D shows a stage where first disposable sub-assembly (502) hasbeen translated proximally to a point where guide pin (526) hastraversed third portion (626) of guide channel (620) in outer tube(580). During the transition from the state shown in FIG. 33C to thestate shown in FIG. 33D, the proximal end of outer tube (580) hasdeflected the distal ends of arms (654) inwardly, thereby driving prongs(656) inwardly. As noted above, this deflection is accommodated bylongitudinally extending slots (594) of proximal inner tube member(590). When outer tube (580) reaches the longitudinal position whereprongs (656) are aligned with openings, the resilience of arms (654)drives prongs (656) outwardly such that prongs (656) snap into place inopenings (630). Thus, at this stage outer tube (580) is coupled withtube actuator (650) such that outer tube (580) will translatelongitudinally with tube actuator (650). Flange features (632) reinforcethe coupling between prongs (656) and the edges of openings (630).

With assembly completed as shown in FIG. 33D, third portion (626) isdimensioned to enable outer tube (580) to translate relative to guidepin (526) during the translation of outer tube (580) that would berequired to pivot clamp arm (570) toward and away from blade (560) asdescribed above. Third portion (626) is also dimensioned to provideenough clearance for knob member (520) and guide pin (526) to betranslated distally relative to outer tube (580) to initiate disassemblyof first disposable sub-assembly (502) from second disposablesub-assembly (504) as described in greater detail below.

In the series shown in FIGS. 34A-34F, first disposable sub-assembly(502) appears to remain fixed in place while second disposablesub-assembly (504) moves. However, it should be understood that anoperator may in fact hold second disposable sub-assembly (504)stationary and move first disposable sub-assembly (502) in order totransition through the stages shown in FIGS. 34A-34G. As shown in FIG.34A, sub-assemblies (502, 504) are initially positioned such that thecurved distal tip of blade (560) is oriented downwardly as outer tube(580) is slid proximally along blade (560), waveguide (562), andproximal inner tube portion (590). This angular positioning may be thesame as that shown in FIGS. 33A-33B.

In the event that outer tube (580) is slid proximally along blade (560),waveguide (562), and proximal inner tube portion (590) at a differentangular orientation, the distal end of blade (560) will eventuallyengage one or more bearing surfaces (607, 608, 609). When the operatorcontinues to retract outer tube first disposable sub-assembly (502)proximally, a camming engagement between the distal end of blade (560)and the one or more bearing surfaces (607, 608, 609) will urge firstdisposable sub-assembly (502) to rotate about the longitudinal axis ofouter tube (580) until the angular relationship shown in FIGS. 33A-33Band 34A-34C is achieved. It should be understood that this angularrelationship may be necessary in order for the distal end of blade (560)to traverse gap (601). It should also be understood that during thestages shown in FIGS. 34A-34C, studs (592) of proximal inner tube member(590) are oriented along an axis that is perpendicular to an axispassing through the centers of openings (582) of outer tube (580).

As first disposable sub-assembly (502) translates proximally through therange of motion where guide pin (526) traverses second portion (624) ofguide channel (620), the engagement between guide pin (526) and guidechannel (620) causes first disposable sub-assembly (502) to rotate 90°about the longitudinal axis of outer tube (580) as noted above. Thisrotation is also shown in FIG. 34D. At this stage, studs (592) ofproximal inner tube member (590) are oriented along an axis that isparallel to an axis passing through the centers of openings (582) ofouter tube (580). In addition, blade (560) is now at the orientationshown in FIGS. 8-9, such that the laterally oriented curve of blade(560) complements the laterally oriented curve of clamp arm (570).

As the operator continues to retract first disposable sub-assembly (502)proximally relative to second disposable sub-assembly (504), studs (592)of proximal inner tube member (590) engage bearing surfaces (607) ofarms (604) of distal inner tube member (600). As the operator continuesto retract first disposable sub-assembly (502) proximally relative tosecond disposable sub-assembly (504), this engagement causes theproximal ends of arms (604) to deflect outwardly as shown in FIG. 34E.Openings (582) of outer tube (580) accommodate this deflection. As theoperator continues to retract first disposable sub-assembly (502)proximally relative to second disposable sub-assembly (504), studs (592)eventually reach openings (606) in arms (504). At this stage, theresilience of arms (504) drives the proximal ends of arms (504) backinwardly, such that studs (592) snap into place in openings (606) asshown in FIG. 34F. At this stage, sub-assemblies (502, 504) are coupledtogether such that disposable assembly (500) is ready for assembly withthe variation of reusable assembly (200). It should be understood thatthe state shown in FIG. 34F corresponds with the state shown in FIG.33D.

D. Exemplary Disassembly of First Disposable Sub-Assembly from SecondDisposable Sub-Assembly

As noted above, first disposable sub-assembly (502) may be configuredfor just one single use while second disposable sub-assembly (504) maybe configured for 2 to 20 uses (or any other suitable number of uses).It may therefore be desirable to enable an operator to disassemble firstdisposable sub-assembly (502) from second disposable sub-assembly (504)without destroying second disposable sub-assembly (504). To that end,FIGS. 35A-36B show various stages of disassembling first disposablesub-assembly (502) with second disposable sub-assembly (504). Inparticular, FIGS. 35A-35E show various stages occurring at the proximalend of first disposable sub-assembly (502) during a process ofdisassembling first disposable sub-assembly (502) from second disposablesub-assembly (504); while FIGS. 36A-36B show various stages occurring atthe proximal end of first disposable sub-assembly (502) during a processof disassembling first disposable sub-assembly (502) from seconddisposable sub-assembly (504).

As shown in FIG. 35A, prongs (524) of knob member (520) are initiallylocated at positions that are proximal in relation to the positions ofprongs (656) of tube actuator (650). This longitudinal offset mayprevent an operator from inadvertently disengaging prongs (656) fromouter tube (580) during use of disposable assembly (500) in a fullyassembled instrument. In order to initiate disassembly, the operator mayneed to first translate knob member (520) distally relative to the othercomponents, as shown in FIG. 35B. In some versions, knob member (520) isresiliently biased to maintain the proximal positioning as shown in FIG.35A. Once knob member (520) has been translated distally to the positionshown in FIG. 35B, prongs (524) of knob member (520) are aligned withprongs (656) of tube actuator (650), though prongs (524) of knob member(520) are laterally spaced form prongs (656) of tube actuator (650). Insome variations, knob member (520) is not translatable, such that prongs(524) of knob member (520) are aligned with prongs (656) of tubeactuator (650) during normal use of disposable assembly (500) in a fullyassembled instrument.

After translating knob member (520) distally to the position shown inFIG. 35B, the operator may press cantilevered buttons (522) inwardly asshown in FIG. 35C. In this example, both buttons (522) are pressedinwardly simultaneously. This drives prongs (524) inwardly. As prongs(524) move inwardly, prongs (524) bear against prongs (656), therebydeflecting the distal ends of arms (654) inwardly. This deflection atleast partially unseats prongs (656) from openings (630) in outer tube(580). With prongs (656) at least partially unseated from openings (630)in outer tube (580), the operator may pull distally on first disposablesub-assembly (502) while holding second disposable sub-assembly (504)stationary (while still pressing cantilevered buttons (522) inwardly).This will ultimately result in the proximal end of outer tube (580)clearing prongs (524) of tube actuator as shown in FIG. 35D. As notedabove, the cantilevered edges of prongs (524) may further promote thisclearing. With outer tube (580) clear of prongs (524), arms (654) mayresiliently transition back to the straight, parallel orientations asshown in FIG. 35D. In addition, with outer tube (580) clear of prongs(524), the operator is free to pull first disposable sub-assembly (502)clear from the remainder of second disposable sub-assembly (504). Theoperator may then dispose of first disposable sub-assembly (502); andclean, sterilize, and re-use second disposable sub-assembly (504) ifappropriate.

It should be understood that during the process of disassembly shown inFIGS. 35A-35D, first disposable sub-assembly (502) may rotate relativeto second disposable sub-assembly (504), about the longitudinal axis ofouter tube (580), due to interaction between guide pin (526) and guideslot (620) as described above.

It should also be understood that, since distal inner tube member (600)is longitudinally secured to proximal inner tube member (590) via arms(604) and studs (592), there will be some degree of relative movementbetween outer tube member (580) and distal inner tube member (600)during the disassembly of first disposable sub-assembly (502) fromsecond disposable sub-assembly (504). This relative movement is shown inFIGS. 36A-36B. When the operator begins the disassembly process andpulls distally on outer tube (580), the inwardly directed tabs (584) ofouter tube (580) will eventually engage bearing surfaces (607) of arms(604). This will provide a camming action that eventually causes theproximal ends of arms (604) to deflect outwardly as shown in FIG. 36B.As noted above, openings (582) of outer tube (580) accommodate thisoutward deflection of the proximal ends of arms (604). Arms (604) willdeflect to the point where studs (592) are no longer located in openings(606) of arms (604). This disengagement of studs (592) from arms (604)will decouple distal inner tube member (600) from proximal inner tubemember (590), thereby enabling distal inner tube member (600) to traveldistally with outer tube (580) as the operator continues to pull outertube (580) distally to complete the disassembly of first disposablesub-assembly (502) from second disposable sub-assembly (504).

III. Exemplary Alternative Disposable Assembly for Ultrasonic SurgicalInstrument with Removable Acoustic Waveguide and Multipurpose AssemblyTool

In some instances, it may be desirable to have an assembly tool that maybe utilized to properly couple first disposable sub-assembly (502, 1502)with second disposable sub-assembly (504, 1504); and also be utilized toproperly couple ultrasonic blade (560, 1560) with reusable assembly(200). Having a single tool that may be used to properly couple multipleassemblies and sub-assemblies may save time and simplify the assemblyprocess.

FIGS. 37-38 show an exemplary alternative disposable assembly (700) thatis coupled to alternative reusable assembly (400). To the extent thatthe following discussion omits various details of disposable assembly(700), it should be understood that disposable assembly (700) mayincorporate the various details described above and/or details describedin any of the various references that are cited herein. Other suitabledetails will be apparent to those of ordinary skill in the art in viewof the teachings herein.

It should be understood that reusable assembly (400) may besubstantially similar to reusable assembly (200) described above, withdifferences described below. Therefore, reusable assembly (400)comprises various features that are operable to activate an ultrasonicblade (760), including an ultrasonic transducer (406). Reusable assembly(400) may include a battery or may be connected to a generator via wiresin order to activate ultrasonic transducer (406). As best seen in FIGS.63A and 64A-64B, reusable assembly (400) includes a coupling shaft (404)rotationally fixed to a distally extending threaded stud (402) oftransducer (406). As will be described in greater detail below, reusableassembly (400) may be rotated relative to disposable assembly (700) inorder to couple disposable assembly (700) with reusable assembly (400).

Disposable assembly (700) of the present example comprises a firstdisposable sub-assembly (702) and a second disposable sub-assembly(704). Sub-assemblies (702, 704) are configured to be coupled togetherin order to form disposable assembly (700), which may then be coupledwith a variation of reusable assembly (400) for form a completeultrasonic surgical instrument. After the ultrasonic surgical instrumentis used in a surgical procedure, disposable assembly (700) may beremoved from the variation of reusable assembly (400); and then firstdisposable sub-assembly (702) may be removed from second disposablesub-assembly (704). In some such instances, the variation of reusableassembly (400) may be cleaned, sterilized, and re-used up to 100 times(by way of example only). First disposable sub-assembly (702) may bedisposed of, such that first disposable sub-assembly (702) is only usedone single time. Second disposable sub-assembly (704) may be cleaned,sterilized, and re-used between 2 to 20 times (by way of example only).Of course, these re-use scenarios are merely illustrative examples. Itshould nevertheless be understood that the configuration of disposableassembly (700) may minimize the amount of single-use material that isdisposed of after each surgical procedure. This may reduce cost andoverall waste as compared to conventional instrumentation.

A. Exemplary First Disposable Sub-Assembly

As shown in FIGS. 37-40, first disposable sub-assembly (702) of thepresent example comprises an outer tube (780), a clamp arm (770), and adistal inner tube member (800). Clamp arm (770) is configured to form anend effector (750), as shown in FIG. 39, with an ultrasonic blade (760),which is part of second disposable sub-assembly (704) as will bedescribed in greater detail below. Clamp arm (770) is pivotably coupledwith outer tube (780) and with distal inner tube member (800). Outertube (780) is configured to translate longitudinally while distal innertube member (800) remains stationary, which drives clamp arm (770) topivot between an open position and a closed position. In the closedposition, clamp arm (770) is operable to clamp tissue against blade(760), which may then be ultrasonically activated to sever and/or sealthe tissue as described herein and in various references cited herein.

As shown in FIG. 40, clamp arm (770) of the present example comprises apair of pin openings (772), a clamp pad (774), and a pair of pivot studs(776). Pin openings (772) are configured to receive a pin (810), whichis also disposed in a pin opening (802) of distal inner tube member(800). Clamp pad (774) of the present example comprisespolytetrafluoroethylene (PTFE) and includes surface features (e.g.,teeth or ridges, etc.) that are configured to promote gripping oftissue. Various suitable materials and configurations that may be usedto form clamp pad (774) will be apparent to those of ordinary skill inthe art in view of the teachings herein. Pivot studs (776) are receivedin openings (786) of outer tube (780). Clamp arm (770) is pivotableabout axes defined by pivot studs (776) and by pin (810), which enablesclamp arm (770) to transition between the open position and the closedposition in response to translation of outer tube (780) relative todistal inner tube member (800).

As shown in FIGS. 40-43, distal inner tube (800) of the present examplecomprises a distal portion (803) defining a pair of lateral openings(812), a pair of proximally presented tabs (812), a proximal portion(801), pin opening (802), and a circumferential tab (804) extending intoa flat member (806) terminating into an outwardly extending lip (807).Circumferential tab (804) and flat member (806) are resiliently flexibleand are in a relaxed position as shown in FIGS. 40-43. Each proximallypresented tab (812) extends inwardly from a respective lateral opening(812). Flat member (806) defines a slot (808). As best seen in FIG. 42,proximal portion (801) defines a pathway (816) extending wordscircumferential tab (805) and flat member (806). A gap (805) extendsfrom proximal portion (801) through distal portion (803). This gap (805)is configured to accommodate longitudinal travel of the distal end ofultrasonic blade (760) during assembly of first disposable sub-assembly(602) with second disposable sub-assembly (604), as will be described ingreater detail below.

As will also be described in greater detail below, distal inner tubemember (800) is configured to be removably secured to a proximal innertube member (790) during assembly of first disposable sub-assembly (702)with second disposable sub-assembly (704). This coupling provides alongitudinal mechanical grounding for distal inner tube member (800),such that distal inner tube member (800) does not translatelongitudinally relative to other components of disposable assembly (700)when inner tube members (790, 800) are coupled together.

As shown in FIG. 40, the distal end of outer tube (780) of the presentexample comprises openings (786) that pivotally receive pivot studs(776) as noted above. The distal end of outer tube (780) furtherincludes an elongate lateral opening (782) that is located proximal toopenings (786). Outer tube (780) is slidably disposed about distal innertube member (800), such that outer tube (780) is operable to translatelongitudinally relative to distal inner tube member (800).

As shown in FIGS. 43-44, the proximal end of outer tube (780) of thepresent example comprises a coupling feature (820). Coupling feature(820) comprises an overmolded portion (822) fixed relative to the restof outer tube (780), a guide projection (826) extending radially fromovermolded portion (822), a pair of proximally presented sleeves (828)spaced 180° relative from each other, and a pair resilient tabs (830)extending proximally relative to overmolded portion (822) and betweenproximally presented sleeves (828). Overmolded portion (822) defines apair of notches (824) presented in the distal direction. As will bedescribed in greater detail below, notches (824) are dimensioned to matewith an end of assembly tool (900) to promote attaching coupling feature(820) to a tube actuator (850) of second disposable sub-assembly (704).Each resilient tab (830) includes an outwardly extending protrusion(832). Each outwardly extending protrusion (832) includes a slopedassembly surface (834), a sloped disassembly surface (838) and a lockingsurface (836). As will be described in greater detail below, slopedassembly surface (834) is configured to promote deflection of resilienttabs (830) during assembly of coupling feature (820) with tube actuator(850), while sloped disassembly surface (836) is configured to promotedeflection of resilient tabs (830) during disassembly of couplingfeature (820) with tube actuator (850), and locking surface (836) isconfigured to promote unitary translation of coupling feature (820) withtube actuator (850).

As will be described in further detail below, outer tube (780) isconfigured to couple with a tube actuator (850) of second disposablesub-assembly (704) when first disposable sub-assembly (702) is coupledwith second disposable sub-assembly (704). Tube actuator (850) isconfigured to drive outer tube (780) longitudinally, to thereby driveclamp arm (770) toward and away from blade (760) as described above.

B. Exemplary Second Disposable Sub-Assembly

As shown in FIGS. 37-38, second disposable sub-assembly (704) of thepresent example comprises a handle assembly (510) having body (711), apistol grip (713), a pivoting trigger (712) pivotally coupled to thebody (711) and pistol grip (713), and a set of buttons (714, 716). Body(711) defines an opening (718) configured to selectively receivereusable assembly (400), as will be described in greater detail below.As best seen in FIG. 38 proximal inner tube member (790) extendsdistally from handle assembly (710). An acoustic waveguide (762) iscoaxially disposed in proximal inner tube member (790) and distallyterminates into ultrasonic blade (760). Waveguide (762) and blade (760)may be configured and operable just like waveguide (192, 592) and blade(190, 590) described above; and/or as described in any of the variousreferences cited herein.

Pistol grip (713) is operable to be grasped by an operator while trigger(712) is operable to drive tube actuator (850) longitudinally inresponse to pivoting trigger (712) toward and away from pistol grip(713). Pivoting trigger (712) toward and away pistol grip (713) therebydrives outer tube (780) longitudinally, to thereby drive clamp arm (770)toward and away from blade (760), when first disposable sub-assembly(702) is coupled with second disposable sub-assembly (704). Structuralfeatures of tube actuator (850) will be described in greater detailbelow. Various suitable components that may be used to providelongitudinal movement of tube actuator (850) in response to pivotalmovement of trigger (712) will be apparent to those of ordinary skill inthe art in view of the teachings herein. By way of example only, trigger(712) may be operatively coupled with tube actuator (850) in accordancewith at least some of the teachings of U.S. Pub. No. 2015/0245850,entitled “Ultrasonic Surgical Instrument with Removable HandleAssembly,” published Sep. 3, 2015, issued as U.S. Pat. No. 10,010,340 onJul. 3, 2018, the disclosure of which is incorporated by referenceherein. In addition, or in the alternative, trigger (712) may beoperatively coupled with tube actuator (850) in accordance with at leastsome of the teachings of U.S. Patent Pub. No. 2016/0015419, entitled“Ultrasonic Surgical Instrument with Removable Handle Assembly,”Published Jan. 21, 2016, the disclosure of which is incorporated byreference herein.

Buttons (714, 716) are operable to activate ultrasonic blade (760). Inparticular, buttons (714, 716) are operable to activate the ultrasonictransducer (406) in the variation of reusable assembly (400), which inturn generates ultrasonic vibrations, which are communicated alongwaveguide (762) to reach blade (760). In some versions, button (714)activates ultrasonic blade (760) with ultrasonic energy at a first setof parameters (e.g., high power); while button (716) activatesultrasonic blade (760) with ultrasonic energy at a second set ofparameters (e.g., low power). As another merely illustrativealternative, button (714) may activate ultrasonic blade (760) withultrasonic energy; while button (716) activates end effector (750) toapply RF electrosurgical energy. Various suitable ways in which this maybe carried out, as well as various other suitable ways in which buttons(714, 716) may be configured, arranged, and operable will be apparent tothose of ordinary skill in the art in view of the teachings herein.

As best seen in FIGS. 45 and 47, proximal inner tube member (790) isdisposed coaxially about waveguide (762) yet is radially spaced apartfrom waveguide (762) such that inner tube member (790) does not contactwaveguide (762). As best seen in FIG. 45, a seal member (840) isdisposed around waveguide (792) just distal relative to proximal innertube member (590). As will be described in greater detail below, sealmember is configured to interact with proximally presented tabs (814) ofdistal inner tube (800) to promote correct lateral alignment of distalinner tube (800) relative to waveguide (762).

Seal member (840) may have any suitable geometry known to know in theart in view of the teachings herein. For example, seal member (840) maybe substantially like seal member (640) described above. Seal member(840) is formed of an elastomeric material and is located on waveguide(762) at a longitudinal position corresponding to a node associated withresonant ultrasonic vibrations communicated through waveguide (762).Seal member (840) thus provides structural support between waveguide(762) and proximal inner tube member (790) without substantiallyinterfering with ultrasonic vibrations through waveguide (762). Sealmember (840) also prevents the ingress of fluids into the gap that isdefined between proximal inner tube member (790) and waveguide (762). Itshould be understood that a series of elastomeric members may beinterposed between proximal inner tube member (790) and waveguide (762),at longitudinal positions corresponding to a nodes associated withresonant ultrasonic vibrations communicated through waveguide (762),though such elastomeric members may be configured differently from sealmember (840).

The distal end of proximal inner tube member (790) comprises alongitudinally extending flat surface (796) extending adjacent to alongitudinally extending arched surface (798). The distal end of archedsurface (797) terminates into a chamfered distal end (797). Proximalinner tube member (790) also comprises an integral, outwardly projectingstud (792) extending away from flat surface (796). Stud (792) isconfigured to fit in slot (808) of distal inner tube member (800), tothereby couple inner tube members (790, 800) together as will bedescribed in greater detail below.

Knob member (720) is operable to rotate the shaft assembly that isformed by waveguide (762), inner tube portions (790, 800), outer tube(780), and end effector (750) when first disposable sub-assembly (702)is coupled with second disposable sub-assembly (704). In particular,this shaft assembly is rotatable relative to handle assembly (710). Asbest seen in FIGS. 69-70, knob member (720), proximal inner tube member(790), and waveguide (762) each include a pin hole (722, 791, 766)respectively to receive pin (705) while tube actuator (850) includes apair of translation slots (852) to receive pin (705). Therefore,rotation of knob member (720) rotates waveguide (762), proximal innertube member (790), and tube actuator (850) unitarily. The dimension oftranslation slots (852) promotes translation of tube actuator (850) andouter tube (780) relative to knob member (720) when first disposablesub-assembly (702) is connected to second disposable sub-assembly (704).

As best seen in FIGS. 48-49, knob member (720) includes a distal face(724) defining a keyway (726) extending into knob member (720). Keyway(726) terminates into a rotating path (728). Rotating path (728)increases the inner diameter of knob member (720) for a selectedcircumferential portion of knob member (720). As will be described ingreater detail below, keyway (726) and rotating path (728) aredimensioned to accept guide projection (826) of coupling feature (820)such that outer tube (780) may only couple with tube actuator (850) inone angular orientation about the longitudinal axis. Knob member (720)also includes a pair of guide tabs (730). As will be discussed ingreater detail below, guide tabs (730) may help promote proper lateralalignment of outer tube (780) relative to tube actuator (850). It shouldbe understood that guide tabs (730) are merely optional. Some versionsof knob member (720) may omit guide tabs (730).

As best seen in FIGS. 47 and 50, tube actuator (850) includestranslation slot (852), a first pair of coupling windows (854), and asecond pair of coupling windows (856). As will be described in greaterdetail below, first pair of coupling windows are configured to promotecoupling between tube actuator (850) and outer tube (780). Secondcoupling windows (856) may be used to promote coupling of tube actuator(850) with various suitable components that may be used to providelongitudinal movement of tube actuator (850) in response to pivotalmovement of trigger (712). While coupling windows (856) are currentlyshown to promote coupling of tube actuator (850) with various suitablecomponents that may be used to provide longitudinal movement of tubeactuator (850) in response to pivotal movement of trigger (712), athreaded portion or any other suitable coupling mechanism may be used aswould be apparent to one having ordinary skill in the art in view of theteachings herein.

C. Exemplary Assembly Tool

FIGS. 51-54 show an exemplary assembly tool (900) that may be utilizedto couple first disposable sub-assembly (702) with second disposablesub-assembly (704); and also to couple second disposable sub-assembly(704) with reusable assembly (400). Assembly tool (900) includes aspanner wrench portion (910), a hand grip portion (930), a torque slipportion (950), and a knob grip portion (970). Spanner wrench portion(910) and knob grip portion (970) are located on opposite ends ofassembly tool (900). Spanner wrench portion (910), hand grip portion(930), torque slip portion (950), and knob grip portion (970) eachdefine a pathway (918, 938, 958, 978) respectively. Assembly tool (900)is dimensioned such that distal end of outer tube (780) may be insertedthrough pathway (918, 938, 958, 978). As will be described in greaterdetail below, assembly tool (900) may be inserted to abut againstcoupling feature (820) or knob member (720), depending on whetherspanner wrench portion (910) or knob grip portion (970) is inserted overdistal end of outer tube (780) first.

As best seen in FIGS. 53-54, spanner wrench portion (910) includes apair of prongs (912) extending distally from a central body (915), and apair of wings (914) extending laterally from central body (915). As bestseen in FIG. 54, central body (915) and wings (914) define a cavity(916) dimensioned to be inserted over hand grip portion (930). Cavity(916) may be dimensioned such that spanner wrench portion (910) iscoupled to hand grip portion (930) with an interference fit. Of course,any other suitable method of coupling spanner wrench portion (910) withhand grip portion (930) may be utilized as would be apparent to onehaving ordinary skill in the art in view of the teachings herein, suchas adhesives. As mentioned above, spanner wrench portion (910) alsodefines a pathway (918) for receiving the distal end of outer tube(780).

Hand grip portion (930) includes a central body portion (935) with apair of grips (934) laterally extending from central body portion (935),and a pair of contact protrusions (932). Contact protrusions (932) aredimensioned to face towards torque slip portion (950).

Torque slip portion (950) includes a disc member (952) unitarilyconnected to a shaft member (953). Disc member includes a circularpattern of flat surfaces (954), sloped surfaces (956), and verticalsurfaces (959). Shaft member (953) includes a plurality of resilienttabs (953). Shaft member (953) is dimensioned to fit within pathway(938) of hand grip portion (930). Additionally, resilient tabs (953) areconfigured to abut against the inner circumference of pathway (938) inorder to provide a predetermined biasing force such that contactprotrusions (932) are encouraged to abut against flat surfaces (954) andsloped surfaces (956) of disc member (952). While in the currentexample, resilient tabs (953) are used to provide a biasing force, anyother suitable means of providing a biasing force may be used as wouldbe apparent to one having ordinary skill in the art, such as springs.

Knob gripping portion (970) defines pathway (978) and a gripping surface(976). Gripping surface (976) is dimensioned to cover the surface ofknob member (720) such that knob member (720) is rotationally fixed toknob gripping portion (970). Additionally, knob gripping portion (970)is unitary connected to torque slip portion (950).

Torque slip portion (950) is rotatably disposed within hand grip portion(930). However, the biasing force encouraging contact between contactprotrusions (932) and surfaces (954, 956) promotes a predeterminedfrictional braking force. The frictional braking force between torqueslip portion (950) and hand grip portion (930) may be great enough toencourage hand grip portion (930) and torque slip portion (950) torotate unitarily. However, torque slip portion (950) may slip relativeto hand grip portion (930) if assembly tool (900) experiences a forcegreat enough to overcome the frictional braking force, such as apredetermined amount of torque.

D. Exemplary Assembly of First Disposable Sub-Assembly with SecondDisposable Sub-Assembly

FIGS. 55A-60B show various stages of assembling first disposablesub-assembly (702) with second disposable sub-assembly (704). Inparticular, FIGS. 55A-57B show various stages occurring at the proximalend of first disposable sub-assembly (702) with second disposablesub-assembly (704); while FIGS. 58A-59C show various stages occurring atthe distal end of first deposable sub-assembly (702) during a process ofassembling first disposable sub-assembly (702) with second disposablesub-assembly (704). Additionally, FIGS. 60A-60B show how assembly tool(900) may be utilized to install first disposable sub-assembly (702)with second disposable sub-assembly (704).

It should be understood that during the process shown in FIGS. 55A-83B,an operator may grasp first disposable sub-assembly (702) in one hand,grasp second disposable sub-assembly (704) in the other hand, and thenmove first disposable sub-assembly (702) relative to second disposablesub-assembly (704) (while holding knob member (720) stationary) in orderto accomplish the process. Alternatively, as shown in FIGS. 60A-60B, anoperator may insert assembly tool (900), spanner wrench portion (910)first, over the distal end of first disposable sub-assembly (702) andmanipulate first disposable sub-assembly (702) with assembly tool (900)

FIGS. 55A-55B show the same movement as shown in FIGS. 56A-56C.

However, knob member (720) is omitted from FIGS. 56A-56D in order toenable visualization of the components that would otherwise be obscuredby knob member (720). FIGS. 55A-55B show that as the proximal end ofouter tube (780) is being inserted within knob member (720), keyway(726) and guide projection (826) must be aligned so that couplingfeature (820) may be inserted into knob member (720). As shown in FIG.56A, first disposable sub-assembly (7020 is at a distal position. Atthis stage, the proximal end of outer tube (780) is distal relative tothe distal end of tube actuator (850). As shown in FIG. 56B, theproximal end of outer tube (780) may be advanced proximally such thatthe proximal end of resilient tabs (830) and proximally presentedsleeves (828) initially enter the distal end of tube actuator (850). Itshould be understood that at this point, outwardly extending protrusions(832) are not within tub actuator (850). Additionally, it should beunderstood that outwardly extending protrusions (832) are dimensioned toradially extend past the diameter of tube actuator (850) when resilienttabs (830) are in a relaxed position.

As shown in FIG. 56C, the proximal end of outer tube (780) may befurther advanced in the proximal direction such that proximallypresented sleeves (828) and resilient tabs (830) are within the confinesof tube actuator (850). It should be understood that as the proximal endof outer tube (780) is advanced within tube actuator (850), the distaledge of tube actuator (850) abuts against sloped assembly surface (834)of outwardly extending protrusions (832) to drive resilient tabs (830)from a relaxed position to an inwardly flexed position. Additionally,when resilient tabs (830) are within the confines of tube actuator (850)as shown in FIG. 56C, the inner diameter of tube actuator (850) makescontact with outwardly extending protrusions (832) to keep resilienttabs (930) in the inwardly flexed position.

As shown in FIG. 56D, an operator may then rotate outer tube (780) inthe clockwise direction (facing proximally) such that proximallypresented sleeves (828) and resilient tabs (830) rotate within theconfines of tube actuator (850). An operator may rotate outer tube (780)until outwardly extending protrusions (832) align with first couplingwindows (854). When outwardly extending protrusions (832) align withfirst coupling windows (854), the inner diameter of tube actuator (850)no longer makes contact with outwardly extending protrusions (832).Therefore, there is no external force keeping tabs (830) in the inwardlyflexed position and the resilient nature of tabs (830) returns tabs(830) to the relaxed position. In the relaxed position, as shown in FIG.56D, outwardly extending protrusions (832) radially extend past thediameter of tube actuator (850). It should be understood that lockingsurface (836) and sloped disassembly surfaces (838) may makes contactwith a perimeter of first coupling window (854) such that the resilientnature of tabs (830) causes contact between surfaces (836, 838) andperimeter of first coupling window (854), to provide an interface fitbetween outer tube (780) and tube actuator (850). This inference fit mayallow for selectively coupling outer tube (780) and tube actuator (850)such that unitary longitudinal translation of tube actuator (850) andouter tube (780) are achieved. Of course, any other suitable means ofproviding unitary longitudinal translation can be used as would beapparent to one having ordinary skill in the art in view of theteachings herein. For example, first coupling window (854) may bedimensioned to contact portions of locking surface (836) and slopedassembly surface (834) when coupling tube actuator (850) and outer tube(780).

FIGS. 57A-57B show that once outer tube (780) is inserted such thatguide projection (826) is inserted within keyway (726) of knob member(720) as shown in FIGS. 55B, 56C, and 57A, rotating path (728) restrictsrotation of outer tube (780) to a single direction due to interactionbetween guide projection (826) and rotating path (728). This may helpensure that end effector (750) is has proper rotational alignment whenfirst disposable sub-assembly (702) is coupled with second disposablesub-assembly (704).

Additionally, guide tabs (730) are dimensioned to ensure proper lateralalignment as tube actuator (850) longitudinally translates outwardlyextending protrusions (832) past guide tabs (730). This may help ensurethat blade (760) has proper lateral alignment compared to clamp arm(770) as clamp arm (770) rotates toward and away from blade (760).However, as noted above, it should be understood that guide tabs (730)are merely optional. Guide tabs (730) are omitted in some versions.

In the series shown in FIGS. 58A-58E, first disposable sub-assembly(702) appears to remain fixed in place while second disposablesub-assembly (704) moves. However, it should be understood that anoperator may in fact hold second disposable sub-assembly (704)stationary and move first disposable sub-assembly (702) in order totransition through the stages shown in FIGS. 58A-58E. Additionally,FIGS. 59A-59C show coupling of distal inner tube (800) with proximalinner tube member (790) without outer tube (780) for purposes ofclarity.

As shown in FIGS. 58A and 59A, sub-assemblies (702, 704) are initiallypositioned such that the curved distal tip of blade (760) is orienteddownwardly as outer tube (780) is slid proximally along blade (760),waveguide (762), and proximal inner tube portion (790). This angularpositioning may be the same as that shown in FIGS. 56A-56C.

An operator may then slide first disposable sub-assembly (702) in theproximal direction to the position shown in FIG. 58B so that blade (760)is inserted within gap (805). At this position, flat member (806) isdirectly adjacent to chamfered distal end (797) of arched surface (798).As can be seen from FIGS. 58B to 58C, chamfered distal end (797) isdimensioned such that further proximal movement of disposable assembly(702) causes flat member (806) to deform outwardly relative to therelaxed position of flat member (806). This deformation is due tocontact with arched surface (798). An operator may then further slidefirst disposable assembly (702) proximally to the position shown inFIGS. 58D and 59B. It should be understood, as shown in FIG. 59B, thatstud (792) slides within pathway (816). It should also be understoodthat the position shown in FIGS. 81D and 82B correlates with theposition shown in FIGS. 55B and 79C. At this stage, flat member (806) isstill in an outwardly deformed position due to contact with archedsurface (798). Also at this stage, proximally presented tabs (814) areboth in contact with seal member (840). As mentioned above, seal member(840) is elastomeric. Seal member (840) in contact with proximallypresented tabs (814) may promote lateral and vertical alignment ofdistal inner tube (800) relative to waveguide (762).

An operator may then rotate first disposable assembly (702) relative tosecond disposable assembly (704) to the position shown in FIGS. 58E and59C, such that flat member (806) is adjacent to flat surface (796). Flatmember (806) returns to the relaxed position due to the dimensions offlat surface (796) compared to arched surface (798). Additionally, slot(808) is longitudinally aligned with stud (792) such that rotation, fromthe position shown in FIGS. 58D to 58E and 59B to 59C, snaps stud (792)into slot (808). Outwardly extending lip (807) of flat member (806) mayinterface with camming surface (794) of stud (792) in order to promotestud (792) to snap into slot (808). Stud (792) and slot (808) aredimensioned such that proximal inner tube (790) and distal inner tube(800) are coupled and mechanically grounded to one another.

FIGS. 60A-60B show use of assembly tool (900) to rotate first disposablesub-assembly (702) relative to second disposable sub-assembly (702) fromthe position shown in FIGS. 58D to 58E and 59B to 59C. Prongs (912) mayenter notches (824) of overmolded portion (822), thereby enabling anoperator to utilize hand grip portion (830) to provide greater leveragewhen rotating first disposable sub-assembly (702) relative to seconddisposable sub-assembly (704). This addition of greater leverage mayallow for greater resilience of circumferential tab (804) and resilienttabs (830).

E. Exemplary Disassembly of First Disposable Sub-Assembly with SecondDisposable Sub-Assembly

FIGS. 61A-61B shows an exemplary disassembly of the proximal end offirst disposable sub-assembly (702) with second disposable sub-assembly(704); while FIGS. 85A-85C show an exemplary disassembly of the distalend of first disposable sub-assembly (702) with second disposablesub-assembly (704).

When an operator desires to uninstall first disposable sub-assembly(702) from second disposable sub-assembly, the operator may reverse therotation utilized with tool assembly (900) as shown in FIGS. 60A-60B. Asshown in FIGS. 61A-61B, this reversed rotation causes the perimeter offirst coupling windows (854) to abut against sloped disassembly surfaces(838), pushing outwardly extending protrusions (832) within the confinesof tube actuator (850). With outwardly extending protrusions (832)within the confines of tube actuator (850), outer tube (780) is nolonger coupled with tube actuator (850), and outer tube (780) may bepulled in the distal direction as shown from FIGS. 57C-57A.

Simultaneously, as shown in FIGS. 62A-62C, the reverse rotation of toolassembly (900) as shown in FIGS. 60A-60B may cause flat member (806) todeflect and rotate relative to stud (792) due to slot (808) abuttingagainst camming surface (794). The resilient nature of flat member (806)will allow flat member (806) to deform until slot (808) and stud (792)are no longer coupled. Once stud (792) is no longer confined by slot(808) of flat member (806), first disposable sub-assembly may be pulledin the distal direction and removed.

F. Exemplary Assembly and Disassembly of Reusable Assembly with SecondDisposable Sub-Assembly

FIGS. 63A-63B show that reusable assembly (400) may be selectivelycoupled with second disposable sub-assembly (704). In some instances, itmay be desirable to couple reusable assembly (400) with seconddisposable sub-assembly (704) via a threaded stud (402) of transducer(406) and threaded coupling bore (764) of waveguide (762) with aspecific torque value. If threaded stud (402) of transducer (406) andthreaded coupling bore (764) of waveguide (762) are not coupled with theproper toque value, the complete ultrasonic surgical instrument may notfunction properly. For example, if the torque value is too low,waveguide (760) may inadvertently decouple from ultrasonic transducer(406) during operation. Alternatively, if the torque value is too high,waveguide (760) or threaded stud (402) of transducer (406) may fractureor otherwise suffer some sort of structural defect. The provision of apredetermined torque value therefore prevents the operator from relyingon a torque that is too low; or achieving a torque that is too high.Assembly tool (900) may be utilized to install reusable assembly (400)to second disposable sub-assembly (704) with a predetermined torquevalue.

FIG. 64A-64C shows assembly tool (900) being utilized duringinstallation of reusable assembly (400) with second disposablesub-assembly (704) without a portion of body (711) for purposes ofclarity. FIG. 64A shows assembly tool (900) being inserted over outertube (780) such that knob gripping member (970) is inserted first. Knobgripping member (970) may be advance in the proximal direction as shownin FIG. 64B such that gripping surface (976) is rotationally coupledwith knob member (720). As shown in FIG. 64C, reusable assembly (400)may be inserted distally such that threaded stud (402) of transducer(406) is inserted into threaded coupling bore (764) of waveguide (762)of waveguide (762), thereby coupling reusable member (400) with seconddisposable sub-assembly (704).

FIGS. 65A-65C show what happens when threaded stud (402) of transducer(406) and threaded coupling bore (764) of waveguide (762) are coupledwith sufficient torque. With the predetermined torque level met, thefrictional braking force provided by biasing contact protrusions (932)against disc (952) are overcome, and as a result, contact protrusions(932) start slipping on flat surface (952) and sloped surface (956).Because knob gripping member (970) is fixed to torque slip portion(950), and an operator provides reactionary torsion by gripping handgrip portion (930), further rotation of reusable assembly (400) rotatesunitarily with second disposable sub-assembly (704), and no more torqueis provided between threaded stud (402) of transducer (406) and threadedcoupling bore (764).

If an operator desires to decouple reusable assembly (400) with seconddisposable sub-assembly (704), the operator simply rotates reusableassembly (400) in the opposite direction while holding hand grip portion(930) causing contact protrusion (932) to interact with flat surface(954), which prevents slipping between hand grip portion (930) and knobgripping member (970).

IV. Further Exemplary Alternative Disposable Assembly for UltrasonicSurgical Instrument with Removable Acoustic Waveguide and MultipurposeAssembly Tool

FIGS. 66-67 show an exemplary alternative disposable assembly (1000)that is coupled to alternative reusable assembly (400). To the extentthat the following discussion omits various details of disposableassembly (1000), it should be understood that disposable assembly (1000)may incorporate the various details described above and/or detailsdescribed in any of the various references that are cited herein. Othersuitable details will be apparent to those of ordinary skill in the artin view of the teachings herein.

As best seen in FIGS. 96A-96B, reusable assembly (400) includes acoupling shaft (404) rotationally fixed to a distally extending threadedstud (402) of transducer (406). As will be described in greater detailbelow, reusable assembly (400) may be rotated relative to disposableassembly (1000) in order to couple disposable assembly (1000) withreusable assembly (400).

Disposable assembly (1000) of the present example comprises a firstdisposable sub-assembly (1002) and a second disposable sub-assembly(1004). Sub-assemblies (1002, 1004) are configured to be coupledtogether in order to form disposable assembly (1000), which may then becoupled with a variation of reusable assembly (400) to form a completeultrasonic surgical instrument. After the ultrasonic surgical instrumentis used in a surgical procedure, disposable assembly (1000) may beremoved from the variation of reusable assembly (400); and then firstdisposable sub-assembly (1002) may be removed from second disposablesub-assembly (1004). In some such instances, the variation of reusableassembly (400) may be cleaned, sterilized, and re-used up to 100 times(by way of example only). First disposable sub-assembly (1002) may bedisposed of, such that first disposable sub-assembly (1002) is only usedone single time. Second disposable sub-assembly (1004) may be cleaned,sterilized, and re-used between 2 to 20 times (by way of example only).Of course, these re-use scenarios are merely illustrative examples. Itshould nevertheless be understood that the configuration of disposableassembly (1000) may minimize the amount of single-use material that isdisposed of after each surgical procedure. This may reduce cost andoverall waste as compared to conventional instrumentation.

A. Exemplary First Disposable Sub-Assembly

As shown in FIGS. 66-69, first disposable sub-assembly (1002) of thepresent example comprises a distal outer tube member (1030), a distalinner tube member (1100), and a clamp arm (1070). Clamp arm (1070) isconfigured to form an end effector (1050), as shown in FIG. 68, with anultrasonic blade (1060), which is part of second disposable sub-assembly(1004) as will be described in greater detail below. Clamp arm (1070) ispivotably coupled with distal outer tube member (1030) and with distalinner tube member (1100). Distal outer tube member (1030) is configuredto unitarily translate with proximal outer tube member (1080)longitudinally while distal inner tube member (1100) remains stationary,which drives clamp arm (1070) to pivot between an open position and aclosed position. In the closed position, clamp arm (1070) is operable toclamp tissue against blade (1060), which may then be ultrasonicallyactivated to sever and/or seal the tissue as described herein and invarious references cited herein.

As shown in FIG. 70, clamp arm (1070) of the present example comprises apair of pin openings (1072), a clamp pad (1074), and a pair of pivotstuds (1076). Pin openings (1072) are configured to receive a pin(1110), which is also disposed in a pin opening (1102) of distal innertube member (1100). Clamp pad (1074) of the present example comprisespolytetrafluoroethylene (PTFE) and includes surface features (e.g.,teeth or ridges, etc.) that are configured to promote gripping oftissue. Various suitable materials and configurations that may be usedto form clamp pad (1074) will be apparent to those of ordinary skill inthe art in view of the teachings herein. Pivot studs (1076) are receivedin openings (1086) of outer tube (1080). Clamp arm (1070) is pivotableabout axes defined by pivot studs (1076) and by pin (1110), whichenables clamp arm (1070) to transition between the open position and theclosed position in response to translation of outer tube (1080) relativeto distal inner tube member (1100).

As shown in FIGS. 70-73, distal inner tube (1100) of the present examplecomprises a pair of proximally presented tabs (1106). Distal inner tube(1100) defines pin opening (1102), a pair of slots (1104), and analignment hole (1105). Proximally presented tabs (1106) define a studhole (1108) and an entry channel (1109). Proximally presented tabs(1106) are resilient in that they may flex about stud holes (1108). Agap (1101) extends from proximal portion through distal portion. Thisgap (1101) is configured to accommodate longitudinal travel of thedistal end of ultrasonic blade (1060) during assembly of firstdisposable sub-assembly (1002) with second disposable sub-assembly(1004), as will be described in greater detail below.

As will also be described in greater detail below, distal inner tubemember (1100) is configured to be removably secured to a proximal innertube member (1090) during assembly of first disposable sub-assembly(1002) with second disposable sub-assembly (1004). This couplingprovides a longitudinal mechanical grounding for distal inner tubemember (1100), such that distal inner tube member (1100) does nottranslate longitudinally relative to other components of disposableassembly (1000) when inner tube members (1090, 1100) are coupledtogether.

As shown in FIGS. 69-70 and 74-75, distal outer tube (1030) includes apair of crimps (1032), a proximal circumferential tab (1034), and aninwardly extending nub (1038) connected to the distal end of proximalcircumferential tab (1034). Distal outer tube (1030) also defines analignment hole (1035) while proximal circumferential tab (1034) definesa first channel (1033) and a second channel (1037). Crimps (1032) areslidably housed within slots (1104) such that distal outer tube (1030)may translate longitudinally relative to distal inner tube (1100) butdistal outer tube (1030) remains laterally and vertically aligned withdistal inner tube (1100).

As will be described in greater detail below, the resiliency ofproximally presented tabs (1106) and proximal circumferential tabs(1034) are configured to promote snap fitting between first disposablesub-assembly (1002) and second disposable sub-assembly (1004). As willalso be described below, alignment holes (1035, 1105) are configured tomate with portions of assembly tool (1200) to fix first disposablesub-assembly (1002) relative to assembly tool (1200) during coupling ofthe first disposable sub-assembly (1002) and the second disposablesub-assembly (1004).

B. Exemplary Second Disposable Sub-Assembly

As shown in FIGS. 66-67, second disposable sub-assembly (1004) of thepresent example comprises a handle assembly (1010) having body (1011), apistol grip (1013), a pivoting trigger (1012) pivotally coupled to thebody (1011) and pistol grip (1013), and a set of buttons (1014, 1016).Body (1011) defines an opening (1018) configured to selectively coupleto reusable assembly (400), as will be described in greater detailbelow. As best seen in FIG. 67 a proximal outer tube (1080) extendsdistally from handle assembly (1100). Proximal outer tube (1080) mayinclude a flush port (1300) substantially similar to flush port (1700)for outer tube (1502) mentioned above. Additionally, a proximal innertube member (1090) is coaxially disposed in proximal outer tube (1080)and extends past the distal end of proximal outer tube (1080). Anacoustic waveguide (1062) is coaxially disposed in proximal inner tubemember (1090) and distally terminates in ultrasonic blade (1060).Waveguide (1062) and blade (1060) may be configured and operable justlike waveguide (192, 592, 792) and blade (190, 590, 790) describedabove; and/or as described in any of the various references citedherein.

Pistol grip (1013) is operable to be grasped by an operator whiletrigger (1012) is operable to drive proximal outer tube (1080)longitudinally relative to proximal inner tube (1090) in response topivoting trigger (1012) toward and away from pistol grip (1013).Pivoting trigger (1012) toward and away pistol grip (1013) therebydrives outer tube (1080) longitudinally, to thereby drive clamp arm(1070) toward and away from blade (1060), when first disposablesub-assembly (1002) is coupled with second disposable sub-assembly(1004). Structural features of proximal outer tube (1080) will bedescribed in greater detail below. Various suitable components that maybe used to provide longitudinal movement of proximal outer tube (1080)in response to pivotal movement of trigger (1012) will be apparent tothose of ordinary skill in the art in view of the teachings herein. Byway of example only, trigger (1012) may be operatively coupled withproximal outer tube (1080) in accordance with at least some of theteachings of U.S. Pub. No. 2015/0245850, entitled “Ultrasonic SurgicalInstrument with Removable Handle Assembly,” published Sep. 3, 2015,issued as U.S. Pat. No. 10,010,340 on Jul. 3, 2018, the disclosure ofwhich is incorporated by reference herein. In addition, or in thealternative, trigger (1012) may be operatively coupled with proximalouter tube (1080) in accordance with at least some of the teachings ofU.S. Patent Pub. No. 2016/0015419, entitled “Ultrasonic SurgicalInstrument with Removable Handle Assembly,” published Jan. 21, 2016, thedisclosure of which is incorporated by reference herein.

Buttons (1014, 1016) are operable to activate ultrasonic blade (1060).In particular, buttons (1014, 1016) are operable to activate theultrasonic transducer (406) in the variation of reusable assembly (400),which in turn generates ultrasonic vibrations, which are communicatedalong waveguide (1062) to reach blade (1060). In some versions, button(1014) activates ultrasonic blade (1060) with ultrasonic energy at afirst set of parameters (e.g., high power); while button (1016)activates ultrasonic blade (1060) with ultrasonic energy at a second setof parameters (e.g., low power). As another merely illustrativealternative, button (1014) may activate ultrasonic blade (1060) withultrasonic energy; while button (1016) activates end effector (1050) toapply RF electrosurgical energy. Various suitable ways in which this maybe carried out, as well as various other suitable ways in which buttons(1014, 1016) may be configured, arranged, and operable will be apparentto those of ordinary skill in the art in view of the teachings herein.

As best seen in FIG. 76, proximal inner tube member (1090) is disposedcoaxially about waveguide (1062) yet is radially spaced apart fromwaveguide (1062) such that inner tube member (1090) does not contactwaveguide (1062). A seal member, similar to seal member (640, 840), maybe disposed around waveguide (1092) in similar locations to seal member(640, 840) described above.

The distal end of proximal inner tube member (1090) includes twointegral, outwardly projecting studs (1092) spaced 180° apart about thelongitudinal axis defined by proximal inner tube (1090). As will bedescribed in greater detail below, outwardly projecting studs (1092) areconfigured to snap fit within stud holes (1108) defined by proximallypresented tabs (1106).

As best seen in FIGS. 76-77, the distal end of proximal outer tubemember (1080) includes a distal coupling feature (1082). Distal couplingfeature (1082) may be fixed to proximal outer tube member (1080) throughan interference fit, integral connection, or any other suitable meansknown to a person having ordinary skill in the art in view of theteachings herein. Therefore, distal coupling feature (1082) mayunitarily translate with proximal outer tube member (1080) in responseto trigger (1012) pivoting toward and away from body (1011).

Distal coupling feature (1082) includes a pair distally facing slants(1084) and a pair of protrusions (1088). Distally facing slants (1084)are spaced 180° apart from one another about the longitudinal axisdefined by proximal outer tube member (1080). Additionally, protrusions(1088) are spaced 180° apart from one another about the longitudinalaxis defined by proximal outer tube member (1080). Coupling feature(1082) defines a pair of tab guide channels (1086) extending from thedistal end of coupling feature (1082) and terminating into distallyfacing slants (1084). Coupling feature also includes a pair of unlockingslanted surfaces (1085) which partially define locking channels (1087)that are adjacent to protrusions (1088). As will be described in greaterdetail below, distally facing slants (1084) are configured to raisecircumferential tabs (1034) onto the surface of coupling feature (1082)while distal outer tube member (1030) is advanced proximally towardsproximal outer tube member (1080).

Additionally, locking channels (1087) are configured to provide a snapfitting with nubs (1038) such that distal outer tube member (1030) maycouple with proximal outer tube member (1080). As will also be describedin further detail below, unlocking slanted surfaces (1085) areconfigured to provide a camming surface to aid circumferential tabs(1034) in disassembling with locking channels (1087).

C. Exemplary Assembly Tool

FIGS. 78A-80 show an exemplary assembly tool (1200) that may be utilizedto couple first disposable sub-assembly (1002) with second disposablesub-assembly (1004) and also couple second disposable sub-assembly(1004) with reusable assembly (400). Assembly tool (1200) includes abase member (1210) pivotally coupled with a top member (1230) via hinges(1222), a locating member (1250) housed within base member (1210), and arotating member (1270) rotatably housed within a recess (1215) of basemember (1210).

Base member (1210) includes a tubular surface (1212) extending from afirst end (1211) towards a second end (1213), a deck (1214), a clamp armsurface (1216), an exterior surface (1218), and hinges (1222). Basemember (1210) defines a pathway (1202) extending through first end(1211) and second end (1213) in communication with tubular surface(1212). Pathway (1202) is dimensioned to accept distal outer tube member(1030) and proximal outer tube member (1080) such that second end (1213)of base member (1210) may be adjacent to knob member (1020), as shown inFIG. 96A-115C. Additionally, pathway (1202) at first end (1211) isdimensioned to receive a portion of second disposable sub-assembly(1004) while first disposable sub-assembly (1002) is fixed withinassembly tool (1200) in order to couple or decouple first disposablesub-assembly (1002) with second disposable sub-assembly (1004).

Base member (1210) also defines a pair of locking apertures (1220)extending from deck (1214) through exterior surfaces (1218). Base member(1210) also defines a cavity (1203) as seen in FIGS. 82-83. Cavity(1203) is in communication with bore (1206) extending from tubularsurface (1212) and two bores (1204) extending from deck (1214). As willbe discussed below, bores (1204, 1206) and cavity (1203) promotetranslation of locating member (1250) as top member (1230) pivots towardand away from base member (1210). Cavity is also defined by an annularsurface (1205) dimensioned to house nut (1260) and bolt (1252).

As seen in FIGS. 82 and 84, second end (1213) of base member (1210)defines recess (1215). Additionally, side bores (1219) extend fromrecess (1215) to exterior surface (1218) of base member (1210). Asdescribed above, rotating member (1270) is rotatably housed withincavity (1215). Side bores (1219) each house a plug (1286), plunger(1287), and a spring (1288). Plug (1286) is fixed within side bore(1219), while spring (1288) attaches plug (1286) with plunger (1287). Aswill be described in greater detail below, plunger (1287) and spring(1288) are dimensioned to impart a frictional braking force on selectiveportions of rotating member (1270) such that rotating member (1270) mayrotate unitarily with the rest of assembly tool (1200) until thefrictional braking force is overcome and rotating member (1270) beginsto slip relative to plunger (1287), spring (1288), and therefore basemember (1210).

Top member (1230) includes a hinge (1222), exterior casing (1238), apair of resilient legs (1240) each having a latch (1242) extendingtowards a respective locking aperture (1220), and a transverse wall(1236) including a downwardly presented surface (1232) and an archedsurface (1234).

Locking apertures (1220) are dimensioned to force latches (1242)inwardly as latches (1242) enter locking aperture (1220) through deck(1214). Additionally, locking apertures (1220) are dimensioned torelease latches (1242) outwardly as latches (1242) exit locking aperture(1220) through exterior surface (1218). As shown in FIG. 78B, withlatches (1242) released outwardly while within the portion of lockingaperture (1220) defined by exterior surface (1218), top member (1230) islocked relative to base member (1210). Resilient legs (1240) aresufficiently flexible that an operator may push inwardly on resilientlegs (1240) to unlock latches (1242) from locking aperture (1220).

Additionally, as will be described in greater detail below, archedsurface (1234) is configured to press against a portion of distal outertube member (1230) in order to restrict vertical movement of firstdisposable sub-assembly (1002) when assembly tool (1200) is graspingfirst disposable sub-assembly (1002) in the closed position (as shown inFIG. 89C).

As shown in FIG. 80, locating member (1250) includes a leaf spring(1254) attached to bolt (1253) on one end and attached to connectingmember (1255) on the other end. Connecting member (1255) unitarilycouples two actuating pins (1256) and a locator pin (1258). Eachactuating pin (1256) is slidably housed within a respective bore (1204)while locating pin (1258) is slidably housed within bore (1206). Leafspring (1254) biases connecting member (1255) so that actuating pins(1256) and locating pin (1258) are biased toward the position shown inFIGS. 78A and 87A. As shown in FIGS. 87A-87B, downwardly presentedsurface (1232) of transverse wall (1236) is dimensioned to contactactuating pins (1256) when top member (1230) pivots from an openposition (FIG. 87A) to a closed position (FIG. 87B). This contactbetween downwardly presented surface (1232) and actuating pins (1256)actuates connecting member (1255) and locator pin (1258) in the downwarddirection and also deforms leaf spring (1254). When top member (1230)pivots from the closed position (FIG. 87B) to the open position (FIG.87A), downwardly presented surface (1232) releases from actuating pins(1256), and leaf spring (1254) returns connecting member (1255),actuating pins (1256) and locating pin (1258) to the position shown inFIGS. 78A and 87A.

As best seen in FIGS. 85-86, rotating member (1270) includes a torquegear (1280) unitarily connected to a knob gripping member (1276). Knobgripping member defines a cutout (1274) to accommodate flush port(1300). Torque gear (1280) is rotatably housed within recess (1215)while knob gripping member (1276) is housed outside of recess (1215).Rotating member (1270) also helps define pathway (1202) for insertionover distal outer tube member (1030) and proximal outer tube member(1080). Torque gear (1280) includes a plurality of arched surfaces(1282), slanted surfaces (1284) and locking surfaces (1283) repeating inan annular pattern. Each surface (1282, 1283, 1284) is configured tointeract with plunger (1287) as will be described in greater detailbelow.

FIGS. 88A-88C and FIGS. 89A-89C each show how first disposablesub-assembly may be fixed within assembly tool (1200). First, as shownbetween FIGS. 88A-88B and 89A-89B, first disposable sub-assembly (1002)may be placed on tubular surface (1212) while assembly tool (1200) is inthe open configuration. Distal outer tube (1030) and distal inner tube(1100) may be positioned relative to each other that that alignmentholes (1105, 1035) are longitudinally aligned. Additionally, locatingpin (1258) is dimensioned to insert within alignment holes (1035, 1105)such that distal inner tube member (1100) and distal outer tube member(1030) are longitudinally fixed relative to base member (1210). Becauseclamp arm (1070) is pivotally coupled to both inner distal tube (1100)and outer distal tube (1030), and inner distal tube (1100) and outerdistal tube (1030) may only translate relative to each otherlongitudinally, the longitudinal position of distal inner tube member(1100) relative to distal outer tube member (1030) determines theangular position of clamp arm (1070). Therefore, clamp arm (1070) willbe in a uniform position when locator pin (1258) is within alignmentholes (1035, 1105).

Clamp arm surface (1216) is dimensioned such that clamp pad (1074) restson clamp arm surface (1216) when locator pin (1258) is within alignmentholes (1035, 1105). An operator may then close assembly tool (1200),which as discussed above, drives locator pin (1258) toward the bottom oftubular surface (1212) as shown in FIGS. 88C and 89C It should beunderstood that locator pin (1258) fixes distal outer tube member (1030)and distal inner tube member (1100) in the longitudinal direction whiletubular surface (1212) and arched surface (1234) fix distal outer tubemember (1030) and distal inner tube member (1100) in the vertical andlateral directions. It should also be understood that locator pin (1258)is in a position not to interfere with gap (1101) accepting blade(1060). First disposable sub-assembly (1002) is now fixed relative toassembly tool (1200) at the stage shown in FIGS. 88C and 89C. Withlatches (1242) locking top member (1230) relative to base member (1210),an operator may grasp assembly tool (1200) to manipulate firstdisposable sub-assembly (1002) in order to rotate first disposablesub-assembly (1002) relative to second disposable sub-assembly (1004)with relative ease.

D. Alternative Exemplary Assembly Tool

FIGS. 90-93 show an alternative exemplary assembly tool (2000) that maybe utilized to couple first disposable sub-assembly (1002) with seconddisposable sub-assembly (1004). Assembly tool (2000) includes a firsthalf (2010) pivotally coupled to a second half (2020) via a living hinge(2030). As best seen in FIG. 91, first half (2010) and second half(2020) are almost entirely symmetrical, with the exception of snap fitfeatures (2016, 2026).

As can be seen between FIGS. 90 and 91, first half (2010) and secondhalf (2020) may collapse from a closed position (FIG. 90) to an openposition (FIG. 91). As will be described in greater detail below, firstdisposable sub-assembly (1002) may be inserted between first half (2010)and second half (2020) in the open position, and then first disposablesub-assembly (1002) may be fixed to assembly tool (2000) when first half(2010) and second half (2020) pivot to the closed position. While in thecurrent example, first half (2010) is pivotally coupled to second half(2020) with a living hinge (2030), it should be understood that anysuitable type of pivotal coupling may be utilized as will be apparent toone having ordinary skill in the art in view of the teachings herein.

As best seen in FIG. 91, first half (2010) includes a first matingsurface (2014) and a first valley (2018). A snap fit feature (2016)extends from first mating surface (2014) while a flat (2012) extendsfrom first valley (2018). Similarly, second half (2020) includes asecond mating surface (2024) and a second valley (2028). A snap fitfeature (2026) extends from second mating surface (2024) while a flat(2022) extends from second valley (2028). Flats (2012, 2022) arelongitudinally aligned.

First valley (2018) and second valley (2028) are symmetrical such thatwhen first half (2010) and second half (2020) are closed, valleys (2018,2028) define a disposable assembly channel (2036), a blade channel(2032), and a clamp arm channel (2034). Disposable assembly channel(2036) is dimensioned to receive distal outer tube (1030) and distalinner tube (1100) of first disposable subassembly (1002). Blade channel(2032) is dimensioned to receive ultrasonic blade (1060) when seconddisposable sub-assembly (1004) is being coupled with first disposablesub-assembly (1002). As best seen in FIG. 92, clamp arm channel (2034)is dimensioned to receive clamp arm (1070) at a specified angle relativeto the rest of first disposable sub-assembly (1002).

As mentioned above, because clamp arm (1070) is pivotally coupled toboth inner distal tube (1100) and outer distal tube (1030) while innerdistal tube (1100) and outer distal tube (1030) may only translaterelative to each other longitudinally, the longitudinal position ofdistal inner tube member (1100) relative to distal outer tube member(1030) determines the angular position of clamp arm (1070). Conversely,the angular position of clamp arm (1070) relative to both outer distaltube member (1030) and inner distal tube member (1100) may determine thelongitudinal position of both outer distal tube (1030) and inner distaltube (1100).

Therefore, when clamp arm (1070) is inserted into clamp arm channel(2034) and distal outer tube (1030) is inserted into disposable assemblychannel (2036), distal outer tube (1030) may be located at the samelongitudinal location every time due to the constant angle made by clamparm (1070) housed in clamp arm channel (2034).

In order to fix first disposable sub-assembly (1002) to assembly tool(2000) an operator may insert clamp arm (1070) into a portion of clamparm channel (2034) defined by first half (2010) while assembly tool(2000) is in the open position. Additionally, an operator may insertdistal outer tube (1030) and distal inner tube (1100) into disposableassembly channel (2036) defined by first half (2010). While in thecurrent example, first disposable sub-assembly (1002) is being initiallyinserted into portions of first half (2010), it should be understoodfirst disposable sub-assembly (1002) may be alternatively inserted intoportions of second half (2020). As best seen in FIG. 92, an operator maythen close assembly tool (2000) to fix first disposable sub-assembly(1002) to assembly tool (2000), as will be described in more detailbelow.

At best seen in FIG. 93, flats (2012, 2022) are positioned withinvalleys (2018, 2028) to be inserted within the portion slots (1104) ofdistal inner tube (1100) accommodating crimps (1032) of distal outertube (1030). The force provided from flats (2012, 2022) interfacing withcrimps (1032) inhibits unwanted movement of first disposablesub-assembly (1002) relative to assembly tool (2000). Therefore, firstdisposable sub-assembly (1002) may be considered fixed relative toassembly tool (2000).

Snap fit features (2016, 2026) are dimensioned for an interference fitto couple first half (2010) with second half (2020) when assembly tool(2000) pivots to the closed position (as shown in FIG. 90). Snap fitfeatures (2016, 2026) sufficiently couple first half (2010) with secondhalf (2020) so that an operator may fix first disposable sub-assembly(1002) within assembly tool (2000) in order to assemble or disassemblefirst sub-assembly (1002) with second sub-assembly (1004). However, snapfit features (2016, 2026) may be pulled apart such that an operator maywillingly pivot first half (2010) and second half (2020) from the closedposition to the open position. Therefore, an operator may selectivelyfix first disposable assembly (1002) with assembly tool (2000) orselectively release first disposable assembly (1002) from assembly tool(2000).

E. Exemplary Assembly and Disassembly of First Disposable Sub-Assemblywith Second Disposable Sub-Assembly

FIGS. 94A-95D show an exemplary assembly of first disposablesub-assembly (1002) with second disposable sub-assembly (1004). Itshould be understood that assembly tool (1200, 2000) may be used tograsp first disposable sub-assembly as shown in FIGS. 88C and 89C whileassembling and disassembling disposable assembly (1000), but is left outfor purposes of clarity.

In particular FIGS. 94A-94D show distal outer tube (1030) coupling withproximal outer tube (1080) while FIGS. 95A-95D show distal inner tube(1110) coupling with proximal inner tube (1090). FIGS. 94A-94B and95A-95B show blade (1060) being inserted into gap (1101) with the archof blade (1060) facing downward.

FIG. 94B shows distal outer tube (1030) being inserted over seconddisposable sub-assembly (1004) so that circumferential tab (1034) isinserted within tab guide channel (1086) of distal coupling feature(1082). In particular, inwardly extending nub (1038) is directlyadjacent to distally facing slant (1084) such that circumferential tab(1034) is still in the relaxed position. FIG. 94C shows distal outertube (1030) being further translated in the proximal direction such thatinwardly extending nub (1038) climbs up distally facing slant (1084),causing circumferential tab (1034) to bend upwardly. Additionally,protrusion (1088) travels within first channel (1033) defined bycircumferential tab (1034) while inwardly extending nub (1038) islongitudinally aligned with locking channel (1087). As shown in FIG.94D, second disposable sub-assembly (1002) is then rotated such thatprojection travels within the confines of second channel (1037) andinwardly extending nub (1038) snaps into locking channel (1087). Distalouter tube (1030) is now coupled with proximal outer tube member (1080).Therefore, longitudinal translation of proximal outer tube member (1080)will also translate distal outer tube member (1030) in order to pivotclamp arm (1070) relative to blade (1060).

FIG. 95B shows distal inner tube (1100) being inserted over proximalinner tube (1090) such that stud (1092) travels within entry channel(1109). It should be understood that the position shown in FIG. 95Bcorresponds with the position shown in FIG. 94C. FIG. 95C shows firstdisposable assembly (1002) being rotated such that stud (1092) flexesproximally presented tab (1106) about stud hole (1108). FIG. 95D showsfirst disposable assembly (1002) being further rotated such that stud(1092) snaps into stud hole (1108) and proximally presented tab (1106)returns to its relaxed position. The position of inner distal tube(1100) corresponds with the position shown in FIG. 94D. Distal innertube (1100) is not mechanically grounded with proximal inner tube(1090).

If an operator desires to disassemble first disposable sub-assembly(1002) from second disposable sub-assembly (1004), an operator mustfollow the steps in reverse order. It should be understood thatunlocking slanted surface (1085) is dimensions to allow inwardlyextending nub (1038) to raise circumferential tab (1034) such thatdistal outer tube member (1080) is no longer coupled with proximal outertube member (1080). It should also be understood that an operator mayfix first disposable sub-assembly (1002) with assembly tool (1200) inorder to obtain the desired amount of leverage to disassemble firstdisposable sub-assembly (1002) from second disposable sub-assembly(1004).

F. Exemplary Assembly and Disassembly of Reusable Assembly with SecondDisposable Sub-Assembly

As discussed above, reusable assembly (400) may be selectively coupledwith second disposable sub-assembly (1004) in a similar fashion thatreusable assembly (400) may selectively couple with second disposablesub-assembly (704) discussed above. In some instances, it may bedesirable to install reusable assembly (400) with second disposablesub-assembly (1004) with a specific torque value. Assembly tool (1200)may be utilized to install reusable assembly (400) to second disposablesub-assembly (1204) with a predetermined torque value.

FIG. 96A-96C shows assembly tool (1200) being utilized duringinstallation of reusable assembly (400) with second disposablesub-assembly (1004), with a portion of body (1011) being omitted forpurposes of clarity. FIG. 96A shows assembly tool (1200) being insertedover outer tube (1080) such that knob gripping member (1276) is insertedfirst. Knob gripping member (1276) may be advanced in the proximaldirection as shown in FIG. 96B such that rotating member (1270) isrotationally coupled with knob member (1020). As shown in FIG. 96C,reusable assembly (400) may be inserted distally such that threaded stud(402) of transducer (406) is inserted into threaded coupling bore (1064)of waveguide (1062), thereby coupling reusable member (400) with seconddisposable sub-assembly (1004).

FIGS. 97A-97D show what happens when threaded stud (402) of transducer(406) and threaded coupling bore (1064) are coupled with sufficienttorque. With the predetermined torque level met, the frictional brakingforce provided by plunger (1287) and spring (1288) against torque gear(1280) are overcome, and as a result, plungers (1287) start slipping onarched surface (1282) and slanted surface (1284). Because knob grippingmember (1276) is fixed to torque gear (1280), and an operator providesreactionary torsion by gripping base member (1210) and/or top member(1230), further rotation of reusable assembly (400) rotates unitarilywith rotating member (1270), and no more torque is provided betweenthreaded stud (402) of transducer (406) and threaded coupling bore(1064).

If an operator desires to decouple reusable assembly (400) with seconddisposable sub-assembly (1004), the operator simply rotates reusableassembly (400) in the opposite direction while holding base member(1210) and/or top member (1230), causing plunger (1287) to interact withvertical surface (1283), which prevents slipping between base member(1210) and rotating member (1270).

While in the current example, four first disposable sub-assemblies (702)are used, it should be understood any suitable number of firstdisposable sub-assemblies (702) may be used as would be apparent to onehaving ordinary skill in the art in view of the teachings herein.

V. Exemplary Alternative Ultrasonic Surgical Instrument with RemovableShaft Assembly Portion

FIGS. 98-114 show another exemplary ultrasonic surgical instrument(3000) that may be readily broken down into disposable and reusablecomponents. In particular, surgical instrument (3000) of this examplecomprises a reusable assembly (3400) and a disposable assembly (3700).To the extent that the following discussion omits various details ofreusable assembly (3400) and disposable assembly (3700), it should beunderstood that reusable assembly (3400) and disposable assembly (700)may incorporate the various details described above and/or detailsdescribed in any of the various references that are cited herein. Othersuitable details will be apparent to those of ordinary skill in the artin view of the teachings herein.

When fully assembled, ultrasonic surgical instrument provides an endeffector (3750) that includes an ultrasonic blade (3760) and a clamp arm(3770), which is pivotable toward and away from ultrasonic blade (3760).End effector (3750) is thus operable to grasp, ultrasonically seal, andultrasonically sever tissue as described herein and as described invarious references cited herein. Reusable assembly (3400) comprises anultrasonic transducer (3406), which is operable to convert electricalpower into ultrasonic vibrations, also as described herein and asdescribed in various references cited herein. Ultrasonic transducer(3406) is acoustically coupled with ultrasonic blade (3760) via anacoustic waveguide (3762), portions of which are shown in FIGS. 99, 108,and 114. It should be understood that ultrasonic transducer (3406),ultrasonic blade (3760), and acoustic waveguide (3762) may be configuredin accordance with the teachings of any of the various references citedherein; or in any other suitable fashion.

Disposable assembly (3700) of the present example comprises a firstdisposable sub-assembly (3702) and a second disposable sub-assembly(3704). Sub-assemblies (3702, 3704) are configured to be coupledtogether in order to form disposable assembly (3700), which may then becoupled with reusable assembly (3400) for form a complete ultrasonicsurgical instrument (3000). After ultrasonic surgical instrument (3000)is used in a surgical procedure, disposable assembly (3700) may beremoved from reusable assembly (3400); and then first disposablesub-assembly (3702) may be removed from second disposable sub-assembly(3704). In some such instances, reusable assembly (3400) may be cleaned,sterilized, and re-used up to 100 times (by way of example only). Firstdisposable sub-assembly (3702) may be disposed of, such that firstdisposable sub-assembly (3702) is only used one single time. Seconddisposable sub-assembly (3704) may be cleaned, sterilized, and re-usedbetween 2 to 20 times (by way of example only). Of course, these re-usescenarios are merely illustrative examples. It should nevertheless beunderstood that the configuration of disposable assembly (3700) mayminimize the amount of single-use material that is disposed of aftereach surgical procedure. This may reduce cost and overall waste ascompared to conventional instrumentation.

As shown in FIGS. 98-99, first disposable sub-assembly (3702) comprisesan outer tube (3780). As best seen in FIGS. 108-109, clamp arm (3770) ispivotally coupled with a distally projecting tongue (3782) of outer tube(3780). A coupling member (3010) is fixedly secured to the proximal endof outer tube (3780). As shown in FIGS. 108-109, first disposablesub-assembly (3702) further comprises a distal inner tube member (3100).As best seen in FIGS. 108-109 and 114, distal inner tube member (3100)is also pivotally coupled with clamp arm (3770) via a distallyprojecting tongue (3102) of distal inner tube member (3100). Thus, whenouter tube (3780) translates longitudinally relative to distal innertube member (3100) as will be described in greater detail below, clamparm (3770) will pivot toward and away from ultrasonic blade (3760).

As shown in FIGS. 98-99, second disposable sub-assembly (3704) comprisesa handle assembly (3710), a proximal inner tube member (3790), acousticwaveguide (3762), and ultrasonic blade (3760). Handle assembly (3710)comprises a housing (3718) that defines a pistol grip (3713). Handleassembly (3710) further includes a trigger (3712) that is pivotabletoward and away from pistol grip (3713); and a pair of buttons (3714,3716). Buttons (3714, 3716) are operable to activate ultrasonictransducer (3406) to thereby activate ultrasonic blade (3760). Inparticular, one button (3714) will provide activation of ultrasonicblade (3760) at one power level or profile; while the other button(3716) will provide activation of ultrasonic blade (3760) at anotherpower level or profile. Of course, any other suitable user inputfeature(s) may be used.

Trigger (3712) is operable to actuate clamp arm (3770), such that clamparm (3770) will pivot toward ultrasonic blade (3760) when trigger (3712)us pivoted toward pistol grip (3713); and such that clamp arm (3770)will pivot away from ultrasonic blade (3760) when trigger (3712) uspivoted away from pistol grip (3713). In the present example, thismovement is provided by translating outer tube (3780) longitudinally inresponse to pivotal movement of trigger (3712), while inner tube members(3790, 3100) remain longitudinally stationary. Various suitable ways inwhich outer tube (3780) may be translated longitudinally in response topivotal movement of trigger (3712) will be apparent to those of ordinaryskill in the art in view of the teachings herein. It should also beunderstood that, in some alternative versions, clamp arm (3770) ispivoted by translating inner tube members (3790, 3100) longitudinallywhile outer tube (3780) remains longitudinally stationary.

As shown in FIGS. 99-100, handle assembly (3710) of the present examplefurther includes a knob member (3720). Knob member (3720) is rotatablerelative to housing (3718). When instrument (3000) is fully assembled,knob member (3720) is coupled with acoustic waveguide (3762), inner tubemembers (3790, 3100), and outer tube (3780) such that all of thesecomponents will rotate together unitarily relative to housing (3718).Knob member (3720) also provides guidance to first disposablesub-assembly (3702) when first disposable sub-assembly (3702) is beingcoupled with second disposable sub-assembly (3704). To accomplish this,and as best seen in FIG. 101, knob member (3720) includes a guidechannel (3724) that receives a guide tab (3012) of coupling member(3010) as will be described in greater detail below. As best seen inFIG. 102, guide channel (3724) is in communication with a recess (3726)formed in a sidewall defining a central bore (3722) of knob member(3720). Recess (3726) is configured to accommodate angular movement ofguide tab (3012) relative to knob member (3720) after guide tab (3012)has cleared guide channel (3724) upon sufficient insertion of couplingmember (3010) in bore (3722), as will also be described in greaterdetail below.

A. Exemplary Bayonet Mount with Detents

FIGS. 103-104 show coupling member (3010) in greater detail. As shown,coupling member (3010) includes guide tab (3012), which extendstransversely from an outer sidewall of coupling member (3010). Couplingmember (3010) also includes a pair of bayonet mount tabs (3014) thatextend transversely from the proximal end of coupling member (3010). Inthe present example, bayonet mount tabs (3014) are angularly positioned180° apart from each other, with guide tab (3012) being angularlypositioned 90° apart from bayonet mount tabs (3014). Alternatively,other suitable angular relationships may be provided. As best seen inFIG. 104, coupling member (3010) also includes a pair of detentprotrusions (3016) that extend proximally away from a central shoulderformed in the body of coupling member (3010). Detent protrusions (3016)are at the same angular positions as bayonet mount tabs (3014), thoughdetent protrusions (3016) are longitudinally positioned at anintermediate region of coupling member (3010) in this example. Again,any other suitable positioning may be used for detent protrusions(3016).

FIGS. 105-106 show a coupling member (3730) that is part of handleassembly (3710). Coupling member (3730) is configured to couple withcoupling member (3710) to thereby couple first and second disposablesub-assemblies (3702, 3704) together. Coupling member (3730) is alsocoupled with trigger (3712), such that pivotal movement of trigger(3712) will cause pivotal movement of coupling member (3730). Couplingmember (3730) is also coupled with knob member (3720) such that couplingmember (3730) will rotate unitarily with knob member (3720). However,the coupling between coupling member (3730) and knob member (3720) isconfigured to enable coupling member (3730) to translate relative toknob member (3720). This will in turn accommodate translation of outertube (3780), thereby enabling pivotal movement of clamp arm (3770).

Coupling member (3730) of the present example includes a pair of bayonetslots (3732) and a pair of detent recesses (3742). Each bayonet slot(3732) includes an entry opening (3734) leading to a longitudinallyextending portion (3736), which then leads to an angularly extendingportion (3738). Bayonet slots (3734) are angularly offset from eachother by 180°. Each detent recess (3742) includes an adjacent ridge(3740) with a lead-up ramp (3744). Detent recesses (37420 are alsoangularly offset from each other by 180°.

FIGS. 107A-107E show various stages of assembling first disposablesub-assembly (3702) with second disposable sub-assembly (3704). Itshould be understood that knob member (3720) is omitted from FIGS.107A-107E in order to depict features that would otherwise be obscuredby knob member (3720). In the stage shown in FIG. 107A, the operator hasinserted the shaft assembly portion formed by proximal inner tube member(3790) and acoustic waveguide (3762) into the bore defined by couplingmember (3010) and outer tube (3780). While holding handle assembly(3710) stationary, the operator moves first disposable sub-assembly(3702) proximally to the position shown in FIG. 107B. At this stage,bayonet mount tabs (3014) have just entered entry openings (3734) ofbayonet slots (3732). It should be understood that guide channel (3724)of knob member (3720) and guide tab (3012) of coupling member (3010) areconfigured such that bayonet mount tabs (3014) will not reach entryopenings (3734) of bayonet slots (3732) unless first disposablesub-assembly (3702) is at a particular angular relationship with seconddisposable sub-assembly (3704). Thus, when the operator retracts firstdisposable sub-assembly (3702) proximally, the operator may rotate firstdisposable sub-assembly (3702) as needed in order for guide tab (3012)of coupling member (3010) to enter guide channel (3724) of knob member(3720).

After reaching the stage shown in FIG. 107B, the operator may continueto move first disposable sub-assembly (3702) proximally while holdinghandle assembly (3710) stationary, until reaching the stage shown inFIG. 107C. At this stage, bayonet mount tabs (3014) have reached theproximal ends of the corresponding longitudinally extending portions(3736) of bayonet slots (3732). The operator may detect this positioningvia tactile feedback indicated from the hard stop preventing furtherproximal movement of first disposable sub-assembly (3702) relative tohandle assembly (3710). At this stage, the operator may grasp knobmember (3720) and hold knob member (3720) stationary while rotatingfirst disposable sub-assembly (3702). During this rotation, bayonetmount tabs (3014) traverse the corresponding angularly extendingportions (3738) of bayonet slots (3732). As noted above, theconfiguration of recess (3726) in knob member (3720) will accommodatethe corresponding angular movement of guide tab (3012) relative to knobmember (3720) during this rotation of first disposable sub-assembly(3702).

As the operator rotates first disposable sub-assembly (3702) relative toknob member (3720) and thus relative to coupling member (3730), detentprotrusions (3016) of coupling member (3710) will eventually encountercorresponding lead-up ramps (3744) as shown in FIG. 107D. While theoperator will feel some degree of resistance to further rotation offirst disposable sub-assembly (3702) relative to knob member (3720), theoperator may continue rotating first disposable sub-assembly (3702)relative to knob member (3720) and thus relative to coupling member(3730). Detent protrusions (3016) will ride up corresponding lead-upramps (3744) and along the corresponding adjacent ridges (3740),eventually reaching detent recesses (3742) as shown in FIG. 107E. Oncedetent protrusions (3016) are seated in corresponding detent recesses(3742), bayonet mount tabs (3014) will have completed their travelthrough corresponding bayonet slots (3732), and first disposablesub-assembly (3702) will be fully coupled with second disposablesub-assembly (3704).

After reaching the stage shown in FIG. 107E, the cooperation betweendetent protrusions (3016) and detent recesses (3742) will maintain thecoupling of first disposable sub-assembly (3702) with second disposablesub-assembly (3704) during normal use of instrument (3000). However, theconfiguration of detent protrusions (3016) and detent recesses (3742)will still enable the operator to disassemble first disposablesub-assembly (3702) from second disposable sub-assembly (3704) aftercompleting a surgical procedure. The operator may then dispose of firstdisposable sub-assembly (3702) and reprocess second disposablesub-assembly (3704), if appropriate, for subsequent use. In order todisassemble first disposable sub-assembly (3702) from second disposablesub-assembly (3704), the operator may simply grasp knob member (3720)and rotate first disposable sub-assembly (3702) to re-traverse angularlyextending portions (3738) of bayonet recesses (3732), then pull firstdisposable sub-assembly (3702) distally away from second disposablesub-assembly (3704) once bayonet mount tabs (3014) reach longitudinallyextending portions (3736) of bayonet recesses (3732).

B. Exemplary Stop Member for Inner Tube Assembly

FIGS. 110-112 show distal inner tube member (3100) in greater detail. Asshown, distal inner tube member (3100) includes distally projectingtongue (3102), a resilient latch arm (3104), and a lateral opening(3110). As noted above, distally projecting tongue (3102) is pivotablycoupled with clamp arm (3770). As best seen in FIG. 112, resilient latcharm (3014) includes an inwardly projecting tab (3016). As also best seenin FIG. 112, distal inner tube member (3100) includes an inwardlyprojecting stop member (3112) adjacent to lateral opening (3110).

FIG. 113 shows the distal end of proximal inner tube member (3790) ingreater detail. As shown, proximal inner tube member (3790) includes adistally projecting tongue (3792), a lateral opening (3794), and adistally presented edge (3796). As will be described in greater detailbelow, lateral opening (3794) is configured to cooperate with inwardlyprojecting tab (3016), while edge (3796) is configured to cooperate withstop member (3112).

FIG. 108 shows distal inner tube member (3100) decoupled from proximalinner tube member (3790). It should therefore be understood that firstdisposable sub-assembly (3702) and second disposable sub-assembly (3704)are not coupled together at this stage. FIGS. 109 and 114 show distalinner tube member (3100) fully coupled with proximal inner tube member(3790). At this stage, inwardly projecting tab (3016) is positioned inlateral opening (3794), thereby securing distal inner tube member (3100)with proximal inner tube member (3790). It should be understood that thepositioning of components shown in FIGS. 109 and 114 corresponds withthe positioning of components shown in FIG. 107E.

It should also be understood that, during the transition from the stateshown in FIG. 108 to the state shown in FIG. 109, resilient latch arm(3014) will deflect outwardly as inwardly projecting tab (3016) ridesalong the exterior of proximal inner tube member (3790), until inwardlyprojecting tab (3016) snaps into place in lateral opening (3794). Thedistal end of outer tube (3780) includes a lateral opening (3784) thatis sized and positioned to accommodate this outward deflection ofresilient latch arm (3014) during the transition from the state shown inFIG. 108 to the state shown in FIG. 109.

As shown in FIG. 114, stop member (3112) will abut edge (3796) whendistal inner tube member (3100) is fully coupled with proximal innertube member (3790). It should be understood that this abutment mayprevent distal inner tube member (3100) from inadvertently decouplingfrom proximal inner tube member (3790). For instance, when the operatordrives clamp arm (3770) to clamp on tissue with substantial force, thismay provide a substantial, proximally oriented load on distal inner tubemember (3100). If this occurred without a stop member (3112) engagingedge (3796), the substantial, proximally oriented load on distal innertube member (3100) may eventually cause inwardly projecting tab (3016)to pop out of lateral opening (3794), thereby decoupling distal innertube member (3100) from proximal inner tube member (3790). Thus, withstop member (3112) abutting edge (3796), stop member (3112) and edge(3796) cooperate to transfer the substantial, proximally oriented loadfrom distal inner tube member (3100) to proximal inner tube member(3790). In other words, stop member (3112) and edge (3796) preventinwardly projecting tab (3016) from having to bear any of thesubstantial, proximally oriented load that would result from clamp arm(3770) clamping on tissue with substantial force. Stop member (3112) andedge (3796) may thereby reduce the likelihood of distal inner tubemember (3100) inadvertently decoupling from proximal inner tube member(3790).

VI. Exemplary Combinations

The following examples relate to various non-exhaustive ways in whichthe teachings herein may be combined or applied. It should be understoodthat the following examples are not intended to restrict the coverage ofany claims that may be presented at any time in this application or insubsequent filings of this application. No disclaimer is intended. Thefollowing examples are being provided for nothing more than merelyillustrative purposes. It is contemplated that the various teachingsherein may be arranged and applied in numerous other ways. It is alsocontemplated that some variations may omit certain features referred toin the below examples. Therefore, none of the aspects or featuresreferred to below should be deemed critical unless otherwise explicitlyindicated as such at a later date by the inventors or by a successor ininterest to the inventors. If any claims are presented in thisapplication or in subsequent filings related to this application thatinclude additional features beyond those referred to below, thoseadditional features shall not be presumed to have been added for anyreason relating to patentability.

EXAMPLE 1

A surgical instrument comprising: (a) a reusable assembly comprising anultrasonic transducer; (b) a first disposable sub-assembly comprising aclamp arm; (c) a second disposable sub-assembly comprising: (i) apivotable trigger, and (ii) an ultrasonic waveguide, wherein the seconddisposable sub-assembly is configured to removably coupled with thereusable assembly; wherein the first disposable sub-assembly isconfigured to removably coupled with the second disposable sub-assembly,wherein the pivotable trigger is configured to rotate the clamp armrelative to the ultrasonic waveguide when the first disposablesub-assembly is coupled to the second disposable sub-assembly.

EXAMPLE 2

The surgical instrument of Example 1, wherein the first disposablesub-assembly comprises a first inner tube and a first outer tube,wherein the first outer tube is pivotally coupled to the clamp arm,wherein the first inner tube is pivotally coupled to the clamp arm.

EXAMPLE 3

The surgical instrument of Example 2, wherein the second disposablesub-assembly comprises a second inner tube having a proximal end and adistal end, wherein the second inner tube is configured to removablycouple with the first inner tube at the distal end of the second innertube.

EXAMPLE 4

The surgical instrument of any one or more of Example 2 through 3,wherein the second disposable assembly comprises a knob memberconfigured to rotate the ultrasonic waveguide about a longitudinal axisdefined by the ultrasonic waveguide, wherein knob member houses a tubeactuator, wherein the first outer tube is removable coupled to the tubeactuator.

EXAMPLE 5

The surgical instrument of Example 4, wherein the knob member defines akeyway and a rotation path, wherein the keyway and rotation path areconfigured to align the first disposable sub-assembly when coupled tothe second sub-assembly.

EXAMPLE 6

The surgical instrument of any one or more of Examples 1 through 5,wherein the second disposable sub-assembly has a counting mechanism todetermine how many times the second disposable sub-assembly has beenused.

EXAMPLE 7

An assembly tool for use with any of the surgical instruments ofExamples 1 through 6, where the assembly tool comprises a torque wrenchconfigured to properly couple the reusable assembly with the secondsub-assembly.

EXAMPLE 8

The assembly tool of Example 7, wherein the assembly tool also comprisesa spanner wrench configured to rotate the first sub-assembly relative tothe second sub-assembly.

EXAMPLE 9

The assembly tool of Example 7, wherein the assembly tool is configuredto fix the first sub-assembly relative to the assembly tool.

EXAMPLE 10

The assembly tool of Example 9, wherein the assembly tool comprises abase member and a top member, wherein the top member is configured topivot relative to the base member from an open position to a closedposition, wherein the assembly tool is configured to fix the firstsub-assembly relative to the assembly tool when the top member is in theclosed position.

EXAMPLE 11

The assembly tool of Example 10, wherein the assembly tool is configuredto selectively lock when the top member is in the closed position

EXAMPLE 12

The assembly tool of any one or more of Examples 9 through 11, whereinthe assembly tool further has a locator feature configured to fix thefirst disposable sub-assembly in the same position relative to theassembly tool.

EXAMPLE 13

The assembly tool of Example 12, wherein the locator feature comprises alocator pin.

EXAMPLE 14

The assembly tool of Example 13, wherein the locator pin is biased to afirst position, wherein the locator pin is configured to translate fromthe first position to the a second position in response to the topmember pivoting from the open position to the closed position.

EXAMPLE 15

The assembly tool of any one or more of Example 9 through 14, whereinthe first inner tube comprises a first alignment hole, wherein the firstouter tube each comprises a second alignment hole, wherein the locatorpin is configured to insert through the first alignment hole and thesecond alignment hole.

EXAMPLE 16

The assembly tool of Example 15, wherein the locator pin and the firstinner tube define a gap configured to receive the ultrasonic waveguidewhen the locator pin is in the second position.

EXAMPLE 17

The assembly tool of any one or more of Example 9 through 16, whereinthe assembly tool comprises a tubular surface configured to conform toat least a portion of first outer tube.

EXAMPLE 18

The assembly tool of any one or more of Example 9 through 16, whereinthe assembly tool is pivotable via a living hinge.

EXAMPLE 19

The surgical instrument of Example 6, wherein the second disposablesub-assembly further comprises an indicator, wherein the indicator isconfigured to show whether the second disposable sub-assembly has beenused a predetermined number of times.

EXAMPLE 20

The surgical instrument of Example 19, wherein the indicator isactivated by a button.

EXAMPLE 21

An apparatus, comprising: (a) a body; (b) a shaft assembly, wherein theshaft assembly comprises: (i) an outer tube, (ii) a proximal inner tubemember, (iii) a distal inner tube member, and (iv) an acousticwaveguide; and (c) an end effector, wherein the end effector comprises:(i) an ultrasonic blade acoustically coupled with the acousticwaveguide, and (ii) a clamp arm, wherein a first portion of the clamparm is pivotably coupled with a distal end of the outer tube, wherein asecond portion of the clamp arm is pivotably coupled with a distal endof the distal inner tube member; wherein the outer tube is configured toremovably couple with the body and the distal inner tube member isconfigured to removably couple with the proximal inner tube member suchthat the outer tube, the distal inner tube member, and the clamp arm areconfigured to removably couple with the body and the remainder of theshaft assembly and end effector as a unit.

EXAMPLE 22

The apparatus of Example 21, wherein the distal inner tube membercomprises a resilient latch feature configured to removably secure thedistal inner tube member to the proximal inner tube member.

EXAMPLE 23

The apparatus of Example 22, wherein the outer tube includes a lateralopening configured to accommodate outward deflection of the resilientlatch feature.

EXAMPLE 24

The apparatus of any one or more of Examples 21 through 23, wherein thedistal inner tube member is configured to removably couple with theproximal inner tube member via a snap fitting.

EXAMPLE 25

The apparatus of any one or more of Examples 21 through 24, wherein thebody and the shaft assembly further comprise complementary guidefeatures, wherein the guide features are configured to guide angularpositioning of the clamp arm relative to the ultrasonic blade about alongitudinal axis defined by the shaft assembly.

EXAMPLE 26

The apparatus of Example 25, wherein the guide features comprise abayonet slot.

EXAMPLE 27

The apparatus of Example 26, wherein the bayonet slot is formed in aproximal end of the outer tube.

EXAMPLE 28

The apparatus of Example 26, wherein the body comprises a couplingmember, wherein the bayonet slot is formed in the coupling member.

EXAMPLE 29

The apparatus of any one or more of Examples 21 through 28, wherein thebody includes a coupling member, wherein a proximal end of the outertube is configured to removably couple with the coupling member of thebody.

EXAMPLE 30

The apparatus of Example 29, wherein the coupling member of the body isconfigured to provide a snap fit with the proximal end of the outertube.

EXAMPLE 31

The apparatus of any one or more of Examples 29 through 30, wherein theproximal end of the outer tube comprises a coupling member, wherein thecoupling member of the outer tube is configured to engage the couplingmember of the body to thereby secure the proximal end of the outer tubeto the body.

EXAMPLE 32

The apparatus of Example 31, wherein the coupling member of the outertube and the coupling member of the body comprise complementary detentfeatures, wherein the detent features are configured to removably securethe proximal end of the outer tube to the body.

EXAMPLE 33

The apparatus of any one or more of Examples 21 through 32, wherein thebody comprises a handle assembly.

EXAMPLE 34

The apparatus of Example 33, wherein the handle assembly comprises aknob, wherein the knob is operable to rotate the shaft assembly and theend effector about a longitudinal axis defined by the shaft assembly.

EXAMPLE 35

The apparatus of Example 34, wherein the knob defines a guide channel,the shaft assembly further comprises a guide tab, wherein the guidechannel and the guide tab are configured to restrict insertion of aproximal end of the outer tube into the body based on an angularorientation of the outer tube about the longitudinal axis.

EXAMPLE 36

The apparatus of any one or more of Examples 21 through 35, wherein theproximal inner tube member and the acoustic waveguide are secured to thebody such that the proximal inner tube member and the acoustic waveguideare prevented from translating longitudinally relative to the body.

EXAMPLE 37

An apparatus, comprising: (a) a body; (b) a shaft assembly, wherein theshaft assembly comprises: (i) an outer tube, wherein the entire outertube is configured to be removably coupled with the body, (ii) aproximal inner tube member, wherein the proximal inner tube member isintegral with the body, (iii) a distal inner tube member, wherein thedistal inner tube member is configured to be removably coupled with theproximal inner tube member, and (iv) an acoustic waveguide, wherein theacoustic waveguide is integral with the body; and (c) an end effector,wherein the end effector comprises: (i) an ultrasonic blade acousticallycoupled with the acoustic waveguide, and (ii) a clamp arm, wherein afirst portion of the clamp arm is pivotably coupled with a distal end ofthe outer tube, wherein a second portion of the clamp arm is pivotablycoupled with a distal end of the distal inner tube member.

EXAMPLE 38

The apparatus of Example 37, wherein the outer tube, the distal innertube member, and the clamp arm are configured to removably couple withthe body and the remainder of the shaft assembly and end effector as aunit.

EXAMPLE 39

A method of assembling a surgical instrument, the method comprising: (a)grasping a first sub-assembly, wherein the first sub-assembly comprises:(i) an outer tube, (ii) a distal inner tube portion, and (iii) a clamparm, wherein the clamp arm is pivotably coupled with the outer tube,wherein the clamp arm is further pivotably coupled with the distal innertube portion; (b) grasping a second sub-assembly, wherein the secondsub-assembly comprises: (i) a body, (ii) an acoustic waveguide extendingdistally from the body, (iii) a proximal inner tube portion extendingdistally from the body, and (iv) an ultrasonic blade positioned at adistal end of the acoustic waveguide; and (c) moving the firstsub-assembly relative to the second sub-assembly, thereby securing theouter tube to the body, and thereby securing the distal inner tubeportion to the proximal inner tube portion.

EXAMPLE 40

The method of Example 39, wherein the act of moving the firstsub-assembly proximally relative to the second sub-assembly comprises:(i) moving the first sub-assembly proximally relative to the secondsub-assembly, and (ii) rotating the first sub-assembly relative to thesecond sub-assembly.

VII. Miscellaneous

It should be understood that any of the versions of instrumentsdescribed herein may include various other features in addition to or inlieu of those described above. By way of example only, in addition tothe teachings above, it should be understood that the instrumentsdescribed herein may be constructed and operable in accordance with atleast some of the teachings of U.S. Pat. Nos. 5,322,055; 5,873,873;5,980,510; 6,325,811; 6,773,444; 6,783,524; 9,095,367; U.S. Pub. No.2006/0079874, now abandoned; U.S. Pub. No. 2007/0191713, now abandoned;U.S. Pub. No. 2007/0282333, now abandoned; U.S. Pub. No. 2008/0200940,now abandoned; U.S. Pub. No. 2009/0105750, issued as U.S. Pat. No.8,623,027 on Jan. 7, 2014; U.S. Pub. No. 2010/0069940, issued as U.S.Pat. No. 9,023,071 on May 5, 2015; U.S. Pub. No. 2011/0015660, issued asU.S. Pat. No. 8,461,744 on Jun. 11, 2016; U.S. Pub. No. 2012/0112687,issued as U.S. Pat. No. 9,381,058 on Jul. 5, 2016; U.S. Pub. No.2012/0116265, now abandoned; U.S. Pub. No. 2014/0005701, issued as U.S.Pat. No. 9,393,037 on Jul. 19, 2016; U.S. Pub. No. 2015/0080924, issuedas U.S. Pat. No. 10,172,636 on Jan. 8, 2019; and/or U.S. Pat. App. No.61/410,603. The disclosures of each of the foregoing patents,publications, and applications are incorporated by reference herein. Itshould also be understood that the instruments described herein may havevarious structural and functional similarities with the HARMONIC ACE®Ultrasonic Shears, the HARMONIC WAVE® Ultrasonic Shears, the HARMONICFOCUS® Ultrasonic Shears, and/or the HARMONIC SYNERGY® UltrasonicBlades. Furthermore, the instruments described herein may have variousstructural and functional similarities with the devices taught in any ofthe other references that are cited and incorporated by referenceherein.

To the extent that there is some degree of overlap between the teachingsof the references cited herein, the HARMONIC ACE® Ultrasonic Shears, theHARMONIC WAVE® Ultrasonic Shears, the HARMONIC FOCUS® Ultrasonic Shears,and/or the HARMONIC SYNERGY® Ultrasonic Blades, and the teachings hereinrelating to the instruments described herein, there is no intent for anyof the description herein to be presumed as admitted prior art. Severalteachings herein will in fact go beyond the scope of the teachings ofthe references cited herein and the HARMONIC ACE® Ultrasonic Shears, theHARMONIC WAVE® Ultrasonic Shears, the HARMONIC FOCUS® Ultrasonic Shears,and the HARMONIC SYNERGY® Ultrasonic Blades.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Versions of the devices described above may have application inconventional medical treatments and procedures conducted by a medicalprofessional, as well as application in robotic-assisted medicaltreatments and procedures. By way of example only, various teachingsherein may be readily incorporated into a robotic surgical system suchas the DAVINCI™ system by Intuitive Surgical, Inc., of Sunnyvale, Calif.Similarly, those of ordinary skill in the art will recognize thatvarious teachings herein may be readily combined with various teachingsof U.S. Pat. No. 6,783,524, entitled “Robotic Surgical Tool withUltrasound Cauterizing and Cutting Instrument,” published Aug. 31, 2004,the disclosure of which is incorporated by reference herein.

Versions described above may be designed to be disposed of after asingle use, or they can be designed to be used multiple times. Versionsmay, in either or both cases, be reconditioned for reuse after at leastone use. Reconditioning may include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, someversions of the device may be disassembled, and any number of theparticular pieces or parts of the device may be selectively replaced orremoved in any combination. Upon cleaning and/or replacement ofparticular parts, some versions of the device may be reassembled forsubsequent use either at a reconditioning facility, or by a userimmediately prior to a procedure. Those skilled in the art willappreciate that reconditioning of a device may utilize a variety oftechniques for disassembly, cleaning/replacement, and reassembly. Use ofsuch techniques, and the resulting reconditioned device, are all withinthe scope of the present application.

By way of example only, versions described herein may be sterilizedbefore and/or after a procedure. In one sterilization technique, thedevice is placed in a closed and sealed container, such as a plastic orTYVEK bag. The container and device may then be placed in a field ofradiation that can penetrate the container, such as gamma radiation,x-rays, or high-energy electrons. The radiation may kill bacteria on thedevice and in the container. The sterilized device may then be stored inthe sterile container for later use. A device may also be sterilizedusing any other technique known in the art, including but not limited tobeta or gamma radiation, ethylene oxide, or steam.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

We claim:
 1. An apparatus, comprising: (a) a body comprising a knob; (b)a shaft assembly, wherein the shaft assembly comprises: (i) an outertube, (ii) a proximal inner tube member, (iii) a distal inner tubemember, and (iv) an acoustic waveguide; (c) an end effector, wherein theend effector comprises: (i) an ultrasonic blade acoustically coupledwith the acoustic waveguide, and (ii) a clamp arm, wherein a firstportion of the clamp arm is pivotably coupled with a distal end of theouter tube, wherein a second portion of the clamp arm is pivotablycoupled with a distal end of the distal inner tube member; and (d) anangular orientation assembly comprising: (i) a first guide featureassociated with either the knob or the outer tube, and (ii) a secondguide feature associated with either the knob or the outer tube; whereinthe outer tube is configured to removably couple with the body and thedistal inner tube member is configured to removably couple with theproximal inner tube member such that the outer tube, the distal innertube member, and the clamp arm are configured to removably couple withthe body and the remainder of the shaft assembly and end effector as aunit, wherein the knob is operable to rotate the shaft assembly and theend effector about a longitudinal axis defined by the shaft assembly,wherein the angular orientation assembly is configured to restrictlongitudinal insertion of a proximal end of the outer tube into the bodybased on a first angular orientation of the outer tube relative to theknob about the longitudinal axis, wherein the angular orientationassembly is configured to allow longitudinal insertion of the proximalend of the outer tube into the body based on a second angularorientation of the outer tube relative to the knob about thelongitudinal axis.
 2. The apparatus of claim 1, wherein the distal innertube member comprises a resilient latch feature configured to removablysecure the distal inner tube member to the proximal inner tube member.3. The apparatus of claim 2, wherein the outer tube includes a lateralopening configured to accommodate outward deflection of the resilientlatch feature.
 4. The apparatus of claim 1, wherein the distal innertube member is configured to removably couple with the proximal innertube member via a snap fitting.
 5. The apparatus of claim 1, wherein thebody and the shaft assembly further comprise complementary guidefeatures, wherein the guide features are configured to guide angularpositioning of the clamp arm relative to the ultrasonic blade about alongitudinal axis defined by the shaft assembly.
 6. The apparatus ofclaim 5, wherein the guide features comprise a bayonet slot.
 7. Theapparatus of claim 6, wherein the bayonet slot is formed in a proximalend of the outer tube.
 8. The apparatus of claim 6, wherein the bodycomprises a coupling member, wherein the bayonet slot is formed in thecoupling member.
 9. The apparatus of claim 1, wherein the body includesa coupling member, wherein a proximal end of the outer tube isconfigured to removably couple with the coupling member of the body. 10.The apparatus of claim 9, wherein the coupling member of the body isconfigured to provide a snap fit with the proximal end of the outertube.
 11. The apparatus of claim 9, wherein the proximal end of theouter tube comprises a coupling member, wherein the coupling member ofthe outer tube is configured to engage the coupling member of the bodyto thereby secure the proximal end of the outer tube to the body. 12.The apparatus of claim 11, wherein the coupling member of the outer tubeand the coupling member of the body comprise complementary detentfeatures, wherein the detent features are configured to removably securethe proximal end of the outer tube to the body.
 13. The apparatus ofclaim 1, wherein the body comprises a handle assembly.
 14. The apparatusof claim 13, wherein the handle assembly comprises the knob.
 15. Theapparatus of claim 14, wherein the first guide feature comprises achannel, wherein the second guide feature comprises a guide tab, whereinthe knob defines the channel, wherein the outer tube further comprisesthe guide tab.
 16. The apparatus of claim 1, wherein the proximal innertube member and the acoustic waveguide are secured to the body such thatthe proximal inner tube member and the acoustic waveguide are preventedfrom translating longitudinally relative to the body.
 17. An apparatus,comprising: (a) a body; (b) a shaft assembly, wherein the shaft assemblycomprises: (i) an outer tube defining an elongate opening along an outersurface, wherein the entire outer tube is configured to be removablycoupled with the body, (ii) a proximal inner tube member, wherein theproximal inner tube member is integral with the body, (iii) a distalinner tube member comprising a coupling member, wherein the distal innertube member is configured to be removably coupled with the proximalinner tube member via the coupling member, wherein the elongate openinghouses the coupling member, and (iv) an acoustic waveguide, wherein theacoustic waveguide is integral with the body; and (c) an end effector,wherein the end effector comprises: (i) an ultrasonic blade acousticallycoupled with the acoustic waveguide, and (ii) a clamp arm, wherein afirst portion of the clamp arm is pivotably coupled with a distal end ofthe outer tube, wherein a second portion of the clamp arm is pivotablycoupled with a distal end of the distal inner tube member.
 18. Theapparatus of claim 17, wherein the outer tube, the distal inner tubemember, and the clamp arm are configured to removably couple with thebody and the remainder of the shaft assembly and end effector as a unit.19. A method of assembling a surgical instrument, the method comprising:(a) grasping a first sub-assembly, wherein the first sub-assemblycomprises: (i) an outer tube comprising a first alignment feature, (ii)a distal inner tube portion, and (iii) a clamp arm, wherein the clamparm is pivotably coupled with the outer tube, wherein the clamp arm isfurther pivotably coupled with the distal inner tube portion; (b)grasping a second sub-assembly, wherein the second sub-assemblycomprises: (i) a body comprising a knob, wherein the knob is configuredto rotate the rest of the second sub-assembly about a longitudinal axis,wherein the knob comprises a second alignment feature, (ii) an acousticwaveguide extending distally from the body, (iii) a proximal inner tubeportion extending distally from the body, and (iv) an ultrasonic bladepositioned at a distal end of the acoustic waveguide; (c) aligning thefirst alignment feature of the outer tube with the second alignmentfeature of the knob; and (d) moving the first sub-assembly relative tothe second sub-assembly, thereby securing the outer tube to the body,and thereby securing the distal inner tube portion to the proximal innertube portion, wherein moving the first sub-assembly relative to thesecond sub-assembly further comprises rotating the first alignmentfeature along the longitudinal axis about a path defined by the secondalignment feature.
 20. The method of claim 19, wherein the act of movingthe first sub-assembly proximally relative to the second sub-assemblycomprises: (i) moving the first sub-assembly proximally relative to thesecond sub-assembly, and (ii) rotating the first sub-assembly relativeto the second sub-assembly.